News

GREENLEAF OFFERS FULL PORTFOLIO OF DIGITAL HEALTH SERVICES

Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces the firm’s complete portfolio of services to support companies developing, commercializing, utilizing, and investing in innovative digital health technologies.

“Players in the digital health space face unique challenges in navigating an ever-changing regulatory landscape, as FDA regulators try to keep up with the pace of digital health technology development,” said John Taylor, President, Greenleaf Health, and Principal, Compliance and Regulatory Affairs. “Greenleaf serves as a trusted partner to both large and small clients developing and commercializing innovative digital health technologies as they navigate the complex landscape of FDA regulations and policies.”

STRATEGIC & TECHNICAL GUIDANCE
Greenleaf professionals work as teams specializing in medical devices and combination products; product quality, manufacturing, and compliance; and drug and biological products. Greenleaf’s comprehensive approach provides a full-service engagement that ensures clients can count on expert direction as they encounter complex regulatory challenges. Greenleaf offers the following digital health-focused services:

Regulatory Strategy & Compliance
Greenleaf experts provide insight, clarity, and strategic consultation on digital health topics. Regulatory strategy and compliance services include:

  • Advise clients on FDA regulatory policies, programs, and procedures, including questions related to jurisdiction to regulate, device classification, and potential pathways to market 
  • Partner with clients to design strategies for product development and premarket review
  • Assist with marketing application preparation and submission
  • Provide advice regarding FDA communications, including compliance and regulatory correspondence
  • Advise on FDA labeling and postmarket safety requirements

Advisory Services
Greenleaf professionals assist entities involved in digital health technology investments and transactions. Advisory services include:

  • Perform due diligence and regulatory risk assessments of potential targets
  • Advise investors on opportunities to manage and mitigate risks in order to achieve desired regulatory outcomes
  • Research and analyze regulatory data sources

Regulatory Policy
Greenleaf’s cross-functional teams help clients keep pace with developments and navigate the emerging regulatory landscape. Regulatory policy services include:

  • Identify novel regulatory tools and approaches to optimize the development process
  • Support clients in structuring their regulatory policy capabilities to effectively advance priorities
  • Design and implement strategies that engage stakeholders, leverage alliances, and advance regulatory policy

AREAS OF EXPERTISE
Greenleaf’s team of experts provides guidance to medical device and combination product manufacturers, pharmaceutical and biotechnology companies, trade associations, and other stakeholders implementing and complying with the FDA’s digital health requirements. Because there is no one-size-fits-all approach, each solution is built to fit the targeted needs of the client. Greenleaf regularly provides expertise to the following types of clients:

  • Start-up and mid-size software companies developing digital health mobile apps
  • Drug companies entering the digital health space to enhance the patient or health care provider experience of their products
  • Diagnostic testing companies developing applications to read diagnostic test results
  • Consumer product companies entering the digital health space with limited FDA regulatory experience
  • Investors identifying and evaluating regulatory risks in potential digital health investments
  • Trade associations and global drug and medical device companies developing digital health policy strategies
  • Artificial intelligence (AI) program developers seeking FDA regulatory insight and clarity
  • Telehealth companies partnering with clinical practitioners and life science companies to offer online access to medical products
  • Health policy and research organizations developing, tracking, and responding to digital health policies, legislation, and initiatives
  • Drug and device companies using digital tools to conduct decentralized clinical trials

ABOUT GREENLEAF HEALTH
Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance to companies developing medical products for the U.S. market. For more information on Greenleaf Health, visit greenleafhealth.com.

MARK KRAMER – Former Director of the FDA’s Office of Combination Products – JOINS GREENLEAF

Greenleaf Health, Inc. announces that Mark Kramer, former Director of the FDA’s Office of Combination Products (OCP), has joined the firm as Executive Vice President, Medical Devices and Combination Products.

Mark’s prior experience provides a unique perspective for Greenleaf clients seeking strategic guidance on the development and regulatory review of combination products as well as medical devices, drugs, and biological products. In addition to serving as Director of OCP from 2002 to 2007, Mark was also responsible for establishing the office. In this role, Mark oversaw the development of significant regulations, policies, and practices currently in effect for combination products, including the primary mode of action rule, the cGMP rule, the adverse event reporting rule, numerous guidance documents clarifying the regulation of combination products, and the intercenter consultation process. Mark also has a firsthand understanding, through his management of the FDA’s Product Jurisdiction Program, of how the Agency assigns combination products to Centers for review and determines the regulatory identity of drugs, devices, and biological products for which jurisdiction is unclear or in dispute.

Mark’s work is informed by his training as a biomedical engineer and a 35-year career in medical product regulation that has united technical, front-line regulatory skills with strategic advising and leadership. During his 17 years at the FDA, Mark gained extensive hands-on experience in device evaluation as a lead reviewer and supervisor for a broad range of products: cardiovascular, anesthesiology/respiratory, urology, gastroenterology, surgical, and dental.

Prior to joining Greenleaf, Mark headed an independent consulting practice for over 13 years (2009-2022), advising approximately 200 clients from across the globe, including sponsors of medical devices, combination products, drugs, and biological products, as well as breakthrough and orphan products. In addition to helping clients develop and refine their regulatory strategies, Mark supported sponsors’ regulatory submissions and FDA interactions at all stages of the regulatory process: authoring, strengthening, and submitting initial submissions; developing and critically reviewing responses to FDA-identified deficiencies; preparing for Agency and advisory panel meetings; and advising on cGMPs and adverse event reporting. Mark also spent three years in industry as Chief Regulatory Strategist for GE Healthcare’s medical device business, with executive responsibility for regulatory strategies, processes, and decisions throughout the U.S., Canada, and Latin America. Learn more about Mark Kramer.

About Greenleaf Health

Greenleaf is guided by experts with a combined total of more than 300 years of FDA experience.  Mark joins a distinguished group of professionals at Greenleaf who previously served as leaders throughout the Agency, including: John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Dr. Daniel Schultz, former Director of the FDA’s Center for Devices and Radiological Health (CDRH); Dr. Karen Midthun, former Director of the FDA’s Center for Biologics Evaluation and Research (CBER); Dr. John Jenkins, former Director of the Office of New Drugs for the FDA’s Center for Drug Evaluation and Research (CDER); Dr. Robert Meyer, former Director of CDER’s Office of Drug Evaluation II; Heather Rosecrans, former Director of CDRH’s 510(k) staff; Kate Cook, senior FDA leader in both CDRH and CBER; David Elder, former Director of the FDA’s Office of Regional Affairs and Office of Enforcement; and Cynthia Schnedar, former Director of CDER’s Office of Compliance.

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance to companies developing medical products for the U.S. market.

For more information on Greenleaf Health, visit greenleafhealth.com.

THREE FORMER FDA OFFICIALS JOIN GREENLEAF TEAM

Greenleaf Health announces the addition of three former FDA officials to our team of experts. Julia Barrett, M.D., M.P.H., and Chris Leptak, M.D., Ph.D., will join the Drug and Biological Products Team as Executive Vice President and Senior Vice President, respectively. Grace McNally will join the Product Quality, Manufacturing, and Compliance Team as Senior Vice President. 

Julia Barrett, M.D., M.P.H

Dr. Julia Barrett brings more than 28 years of clinical development and regulatory expertise to her role as Executive Vice President, Drug and Biological Products. Julia began her career as a clinical reviewer in the FDA’s Office of Vaccine Research and Review (OVRR) at the Center for Biologics Evaluation and Research (CBER). Prior to joining Greenleaf, Julia spent more than 17 years as a Senior Clinical Consultant at Biologics Consulting Group, where she focused on clinical product development and U.S. regulatory submissions.

Julia’s product expertise includes cell and gene therapy/regenerative medicine, protein therapeutics, allergy immunotherapy, vaccines, toxins, and microbiome-based products. Julia received her bachelor’s degree in biology from Smith College, an M.D. from Northwestern University, and an M.P.H. from George Washington University (GWU). She trained as a resident in internal medicine at the University of Minnesota and completed a fellowship in general internal medicine at GWU. Learn more about Julia Barrett.

Chris Leptak, M.D., Ph.D.

Dr. Chris Leptak joins Greenleaf following a distinguished 14-year career at the FDA, where much of his work focused on biomarker and diagnostic device utility in clinical trials and drug development. Most recently, Chris served as Associate Director, Regulatory Science in the Office of New Drugs (OND) within the FDA’s Center for Drug Evaluation and Research (CDER). During his FDA tenure, Chris led multiple programs and initiatives aimed at developing CDER’s approach to regulatory science, including as Director of the CDER Biomarker Qualification Program, Director of the OND Regulatory Science Program, and Acting Director of the Office of Drug Evaluation Science.

Chris received his undergraduate degree from Yale University and his M.D./Ph.D. at the University of California, San Francisco. Chris completed his residency in emergency medicine at Harvard’s combined Mass General and Brigham program. Learn more about Chris Leptak.

Grace McNally

Grace McNally brings more than 33 years of FDA service to her role as Senior Vice President, Regulatory Compliance at Greenleaf. Grace’s extensive FDA career is highlighted by multiple leadership positions, including her service as Director of the Division of Regulations, Guidance, and Standards within CDER’s Office of Policy for Pharmaceutical Quality; Branch Chief in the Office of Process and Facilities within CDER’s Office of Pharmaceutical Quality; and Compliance Officer within CDER’s Office of Compliance. Grace began her career at the FDA as a field investigator in the Philadelphia District and later joined the Denver District, where she specialized in pharmaceutical and medical device inspections. Grace received her B.S. in physics from Boston College. Learn more about Grace McNally.

About Greenleaf Health

Greenleaf is guided by experts with a combined total of more than 300 years of FDA experience.  Barrett, Leptak, and McNally join a distinguished group of professionals at Greenleaf who previously served as leaders throughout the Agency, including: John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Dr. Daniel Schultz, former Director of the FDA’s Center for Devices and Radiological Health (CDRH); Dr. Karen Midthun, former Director of the FDA’s Center for Biologics Evaluation and Research (CBER); Dr. John Jenkins, former Director of New Drugs for the FDA’s Center for Drug Evaluation and Research (CDER); Dr. Robert Meyer, former Director of CDER’s Office of Drug Evaluation II; Heather Rosecrans, former Director of CDRH’s 510(k) staff; David Elder, former Director of the FDA’s Office of Regional Affairs and Office of Enforcement; and Cynthia Schnedar, former Director of CDER’s Office of Compliance. 

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance to companies developing medical products for the U.S. market.

For more information on Greenleaf Health, visit greenleafhealth.com.

GREENLEAF HEALTH ANNOUNCES EXPANDED REGULATORY POLICY SERVICES and NEW LEADERSHIP ROLE FOR LONG-TIME GREENLEAF TEAM MEMBER

Greenleaf Health is expanding its regulatory policy services to further support the needs of clients. A dedicated Regulatory Policy Services Team will be guided by long-time Greenleaf team member, Kate Cook, who will assume a new leadership role at the firm as Principal, Regulatory Policy.

“Since joining Greenleaf more than five years ago, Kate has been a source of both immense regulatory knowledge and exceptional strategic skill. Her inherent leadership abilities, which were well known at the FDA, will guide her team as they build on the valuable regulatory policy services our clients seek,” said John Taylor, President, Greenleaf Health, Inc.

Regulatory Policy Services

Greenleaf’s regulatory policy services are designed to support the needs of large and small clients as they navigate FDA regulations and regulatory policies. The firm’s team of experts works cross-functionally to provide a full-service engagement that assists pharmaceutical and biotechnology companies, medical device manufacturers, patient groups, trade associations, and other stakeholders in communicating effectively about FDA regulatory policy issues and in understanding, implementing, and complying with the FDA’s regulatory programs.

With decades of experience in senior positions at the FDA and throughout industry, Greenleaf’s Regulatory Policy Services Team offers unmatched insight on pre- and postmarket regulatory policy issues, product designations, expedited programs, regulatory intelligence, and scientific policy.

Greenleaf experts draw on their extensive institutional knowledge of the FDA’s overarching regulatory approach, as well as deep and granular expertise regarding FDA regulation of medical product types across the product lifecycle, to provide the following services:

  • Assistance with designing and implementing regulatory policy strategies to effectively advance priorities
  • Guidance on policy issues related to development programs, combination products, submissions for marketing authorization, and the postapproval phase
  • Stakeholder engagement and alliance development to achieve regulatory policy goals
  • User fee negotiation support, impact assessment, and program development
  • Strategic regulatory guidance for sponsors seeking access to FDA programs and designations, including orphan drug, breakthrough therapy, RMAT, and other expedited pathways
  • Regulatory landscape analysis and advice on incorporating novel tools and approaches into development programs

About Kate Cook

Kate joined Greenleaf in 2016 following a distinguished career of more than 20 years at the FDA. In her new role as Principal of Regulatory Policy, Kate will build on the experience she gained over the last five years as Executive Vice President of Drug and Biological Products, coupled with her extensive FDA institutional knowledge, to grow the firm’s services focused on FDA regulatory policies and programs.

Kate’s FDA career began in the Office of Chief Counsel, where she served for more than 15 years as a legal counsel on FDA issues related to such medical products as biosimilars, vaccines, allergenics, human tissue and cellular products, blood products, medical devices, and combination products. She also provided legal guidance on issues related to human subject protection and advertising and promotion.

Kate’s FDA experience included roles as Associate Director for Regulations and Policy within the Center for Devices and Radiological Health (CDRH) and Senior Advisor in the FDA’s Center for Biologics Evaluation and Research (CBER). During her FDA tenure, Kate had a pivotal role in the development and implementation of significant policies, regulations, and strategic initiatives related to drugs, biological products, and medical devices. Learn more about Kate Cook.

ABOUT GREENLEAF

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. The firm includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.

Greenleaf is a regulatory consulting firm and does not provide legal advice or legal services.

GREENLEAF HEALTH ANNOUNCES EXPANDED LITIGATION SUPPORT SERVICES

Greenleaf is expanding the firm’s litigation support services to include a network of experienced and knowledgeable FDA experts adept at advising litigators representing FDA-regulated clients. Greenleaf’s litigation support services utilize the firm’s deep bench and network of experienced and knowledgeable FDA experts to advise litigators grappling with FDA regulatory issues and provide authoritative, objective expert opinions that may make a difference in how disputes are resolved.

Comprehensive Services
Greenleaf professionals and the firm’s network of experts work closely with litigators representing FDA-regulated clients in a wide array of disputes related to medical devices, drug and biological products, and product quality, manufacturing, and compliance. The firm offers litigators access to advisors with the knowledge, qualifications, and experience required to explain and clarify complex FDA regulatory issues to clients, the courts, or juries and serve as credible, persuasive expert witnesses.

Services provided by the Litigation Support Services Network include: advising litigators on the nuances of FDA regulation; preparing expert declarations or reports; and testifying during depositions and at trial. Greenleaf’s team has worked with litigators engaged in a variety of disputes, including complex commercial litigation, unfair competition and false advertising cases, intellectual property litigation, product liability class actions, and securities class actions.

Areas of Expertise
Greenleaf professionals and the firm’s network of experts have extensive, in-depth experience regarding medical device product development, drug and biological product development, the premarket review process, as well as manufacturing, product quality and safety, compliance, and enforcement of all FDA-regulated products.

The Greenleaf Litigation Support Services Network can offer litigators a high-level institutional knowledge of the FDA as well as more granular expertise regarding FDA regulation of a variety of product types across the product lifecycle. Greenleaf’s well-regarded professionals have spent decades working at the FDA in senior positions, allowing them to render thoughtful advice and authoritative opinions.

ABOUT GREENLEAF
Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. The firm includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.

Greenleaf is a regulatory consulting firm and does not provide legal advice or legal services.

VALIDANT ACQUIRES GREENLEAF HEALTH

Validant, a leading global quality, compliance and regulatory consulting group (the Group), has acquired Greenleaf Health, Inc. (Greenleaf), a leading U.S. Food and Drug Administration (FDA) regulatory consulting firm. Concurrent with the acquisition, Validant announced the appointment of Patrick Ronan, founder and former Chief Executive Officer (CEO) of Greenleaf, as the new CEO of Validant.

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s team of experts draw on a combined total of more than 300 years of FDA experience to deliver reliable, objective advice to FDA-regulated companies. Founded in 2007, Greenleaf is headquartered in Washington, D.C.

Validant’s acquisition of Greenleaf is another important step in its international growth strategy, focused on combining best-in-class regulatory and quality providers, and accelerating their growth with further investment. The accelerated growth strategy is supported by GHO Capital, the European specialist investor in healthcare, having partnered with Validant since December 2018. Today’s announcement follows Validant’s December 2020 acquisition of Oriel STAT A MATRIX, a New Jersey-based global consultancy and training firm; November 2020 acquisition of IDEC, a leading regulatory consultancy in Japan; and the acquisition of DataRevive in 2019, a regulatory strategy and consultancy for global clients, based in Washington D.C.

Commenting on the announcement, The Partners at GHO Capital, said: “We are delighted to welcome the entire Greenleaf team to Validant. They bring a wealth of complementary experience and expertise to the Group and the combination is set to benefit the customers of both companies. We would like to take this opportunity to thank Brian Burns for his support and leadership in overseeing the rapid growth of Validant. We are excited to continue this trajectory under Patrick’s leadership and believe that his experience and passion will help consolidate our position as the leading global life science regulatory consultancy.”

Patrick Ronan brings more than 25 years of leadership experience to his role as CEO of Validant. Prior to founding Greenleaf in 2007, Patrick served as Vice President of Regulatory Policy & External Affairs at Novartis Pharmaceuticals Corporation, where he supervised U.S. regulatory policy issues and advised all therapeutic areas on FDA-related regulatory matters.  Patrick’s extensive experience includes leadership roles at the FDA where he served as Chief of Staff and Assistant Commissioner of Legislation; on Capitol Hill, where he served as a member of the Professional Staff to the Committee on Energy and Commerce; and the Washington, D.C.-based Biotechnology Innovation Organization (BIO).

Patrick Ronan, newly appointed CEO of Validant, commented: “Greenleaf Health enhances the expertise and capabilities of Validant as we work to support clients and their evolving global regulatory needs. I am excited to serve in the role of CEO and bring our teams together as we create a platform for continued growth and success.”

Fairmount Partners provided investment banking and advisory services, and Goodwin Procter provided legal advice to Greenleaf Health, Inc.

OMM provided legal advice, RSM Global provided financial and accounting advice, and Deloitte provided tax advice to Validant.

About Validant

Validant is a leading international Quality, Compliance, and Regulatory consulting firm, blending industry expertise with innovation to create custom solutions for companies on the frontier of health. With deep experience working within and alongside the FDA and other regulatory agencies, we understand how to navigate the complexities facing today’s healthcare industry. For further information, please visit www.validant.com

About Greenleaf

Greenleaf Health is a leading FDA regulatory consulting firm that provides expert services to FDA-regulated entities. Greenleaf includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Greenleaf’s team of respected professionals work cross-functionally to provide unmatched expertise to companies navigating today’s evolving regulatory environment. For more information on Greenleaf Health, visit www.greenleafhealth.com.

GREENLEAF LANDSCAPE SERIES PROVIDES EXPERT INSIGHT ON EMERGING REGULATORY TOPICS

Greenleaf Health, Inc. (Greenleaf) is expanding the firm’s advisory services portfolio to include a Regulatory Landscape Series that addresses emerging topics related to FDA regulation. Authored by the firm’s expert advisors, these brief analyses provide valuable, timely insight into the current state and future direction of regulatory developments and activity at the FDA.

Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance on developing regulatory matters. A sample of the series topics includes: 

Medical Device EUAs:  Greenleaf experts provide an overview and analysis of the recent activity within the Center for Devices and Radiological Health (CDRH) to address the volume and diversity of Emergency Use Authorization (EUA) requests that have emerged in the in vitro diagnostic (IVD) space as a result of the COVID-19 pandemic. 

COVID-19 Inspections:  Greenleaf compliance experts address FDA inspectional activities during the COVID-19 pandemic and alternative approaches to ensure the continued supply of quality medicines.

COVID-19 Pandemic Accelerates Digitalization of Clinical Trials:  Greenleaf discusses the FDA’s recent support of digital health tools (DHTs) and the impact of digital health technologies in medical product development.

New installments in the Regulatory Landscape Series are published on a regular basis and distributed via Greenleaf e-communication. The complete series is available on the Greenleaf website

The Regulatory Landscape Series is presented by Greenleaf’s Advisory Services Team, which serves as a trusted partner to investors evaluating life sciences transactions. Greenleaf experts provide investors with extensive research and due diligence on potential deals that require regulatory risk analyses before and after decisions and transactions. By working cross-functionally across all areas of expertise, the Greenleaf team is able to offer insight on the FDA’s current thinking in multiple areas and set appropriate expectations for investors. To learn more about Greenleaf’s advisory services, visit the Greenleaf website.

Greenleaf Health is a leading FDA regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.

To be included in future communications, please register by completing the below form:

Regulatory Landscape Series

GREENLEAF PORTFOLIO NOW INCLUDES REMOTE COMPLIANCE SERVICES

Greenleaf Health expands its compliance and manufacturing portfolio to include remote quality and compliance support for clients.

Entities regulated by the FDA encounter challenges on a regular basis. But no recent challenge has placed as great of a strain on the life sciences industry as COVID-19. The impact of this global pandemic is experienced by companies of every size, and increased effort and adaptability are required from all parties to preserve the integrity of the supply chain and ensure a consistent supply of safe, high-quality products.

“Greenleaf Health recognizes that quality and compliance activities cannot be stalled. Despite global disruptions in surveillance inspections and other regulatory operations, Greenleaf’s work on behalf of our clients continues. The firm’s team of experts has identified opportunities to assist clients remotely while continuing to support all public health measures in effect throughout the course of the pandemic,” said John Taylor, President, Greenleaf Health, and Principal, Compliance and Regulatory Affairs.

Greenleaf’s remote compliance services concentrate on the FDA’s evolving alternative approaches to on-site inspections that may exist for many months to come. Although not a full substitution for on-site work, the remote opportunities provided by Greenleaf enable companies to continue essential quality and compliance activities while preparing for the time when on-site activities fully or partially resume.

STRATEGIC & TECHNICAL GUIDANCE
Greenleaf’s Product Quality, Manufacturing, and Compliance Team identifies and promotes practices and procedures that will align a client’s approach with the FDA’s quality, safety, and compliance expectations. Greenleaf also engages a network of independent contractors to provide technical expertise, both on site and remotely.

While companies face the complexities of navigating today’s challenging public health landscape, Greenleaf and our network of independent compliance experts are prepared to assist clients with the following remote quality and compliance services:

  • Procedural and Record Review. Comprehensive review of new or revised Standard Operating Procedures (SOPs) for acceptability and compliance with requirements and objective evaluation of selected records (e.g., deviations, nonconformance reports, OOS, complaints) for accuracy, completeness, and compliance with requirements.
  • Data and Trending Review. Examination of documents and objective feedback on key quality data and metrics, and trending reports prepared for quality or management reviews.
  • Corrective Action Assessment. Evaluation of responses, corrective action records, and change control records related to issues identified by the client, or identified during previous inspections by the FDA and other health authorities, and determination of whether the actions are appropriate, complete, and effective.
  • Regulatory Response Support. Objective review and expert guidance on providing effective responses to FDA 483s, warning letters, requests for additional information, and other critical regulatory correspondence.
  • Issue-Specific Information. Review of information relating to a specific issue of interest identified by the client to provide an objective assessment and feedback to help with resolution, documentation, and communication.
  • Training. Live video training on specific topics such as inspection preparedness, design controls, CAPA, etc.

ABOUT GREENLEAF
Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.

The firm includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.

For more information on remote compliance services and Greenleaf Health, visit greenleafhealth.com.

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GREENLEAF HEALTH EXPANDS COMPLIANCE PORTFOLIO TO INCLUDE GOOD CLINICAL PRACTICE (GCP) SERVICES

WASHINGTON, D.C.  – Greenleaf Health, a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces that the firm has expanded its compliance and manufacturing portfolio to include Good Clinical Practice (GCP) services.

Greenleaf’s in-depth knowledge and understanding of the FDA enables the firm to provide unmatched guidance to companies developing products for the U.S. market. Greenleaf experts work with companies to build GCPs that will align a client’s approach with the FDA’s quality, safety, and compliance expectations.

STRATEGIC & TECHNICAL CAPABILITIES

Greenleaf’s expanded GCP services build-on the firm’s already robust compliance portfolio by working with life science entities to evaluate and strengthen clinical quality systems. Greenleaf’s team of regulatory experts use a risk-based methodology to provide strategic and technical guidance to companies designing and executing clinical trials. Because there is no one-size-fits-all approach to GCP compliance, each solution is built to fit the targeted needs of the client, with an eye toward mitigating risks, optimizing processes, and creating a culture of compliance.

Members of Greenleaf’s Product Quality, Manufacturing, and Compliance Team offer a rare blend of perspective developed as leaders in both the public and private sectors. The firm’s wealth of experience enables experts to deliver valuable regulatory and real-world insight. Greenleaf’s tailored GCP services include: complete quality and compliance system assessments; inspection readiness, including mock inspections; comprehensive auditing services; compliance remediation; quality system and inspection readiness training; FDA communications, including analysis of and responses to enforcement letters and facility and supply chain audit reports; and the complete spectrum of compliance and regulatory consultation and guidance.

EXPERT TEAMS

Greenleaf’s team is comprised of experts with a combined total of more than 250 years of FDA experience. With decades of experience in senior positions at the FDA and throughout industry, Greenleaf’s team of respected professionals understand firsthand the importance of accurate and reliable clinical data.

The collective knowledge and extensive experience of the Greenleaf team is enhanced by Greenleaf’s network of specialized technical experts who can be deployed to provide on-site services at entities that manufacture FDA-regulated products.

FULL-SERVICE SUPPORT

Greenleaf professionals work as teams specializing in product quality, manufacturing, and compliance; medical devices and combination products; and drug and biological products. The firm’s comprehensive approach provides a full-service engagement that ensures clients can count on expert direction as they encounter complex regulatory challenges.

Additional services provided by Greenleaf experts include:

  • Real World Evidence (RWE): Greenleaf has partnered with Trio Health to provide a cutting-edge combination of technology and regulatory insight via Trio Health’s innovative RWE technology platform.
  • Cell & Gene Therapy: Greenleaf assists sponsors of cell and gene therapies by optimizing FDA interactions and submissions to support development, manufacturing, quality, and regulatory review.
  • Advisory Services: Greenleaf understands the complex environment within which life sciences transactions take place and frequently advises investors to evaluate potential issues and regulatory risks that may be identified during such transactions.

ABOUT GREENLEAF

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.

The firm includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.

For more information on GCP services and Greenleaf Health, visit greenleafhealth.com.

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GREENLEAF HEALTH and TRIO HEALTH PARTNER TO APPLY FDA-LEVEL RIGOR TO GROUNDBREAKING DATA PLATFORM

WASHINGTON, D.C, October 1, 2019— Greenleaf Health, a leading Food and Drug Administration (FDA) regulatory consulting firm, today announced it has entered into an exclusive agreement with Trio Health, a leading provider of real-time data on real-world patients, to unite in utilizing and validating the data analyses from the groundbreaking Multi-Disease Platform (MDX) technology platform.

By partnering with Greenleaf, Trio’s advanced analytics MDX platform delivers unrivaled insights to the industry; in particular, the ability to transform real world data into actionable intelligence to innovate and make better decisions across the product lifecycle with confidence.

Trio, founded in 2013, tracks a patient through the entire treatment journey by combining disparate information from the physician, pharmacy, and payer ‘trio,’ to produce comprehensive and high-quality databases that are on caliber with FDA-level rigor.

Greenleaf CEO Patrick Ronan, Trio CEO, Brent Clough, and Greenleaf Principals of Drug and Biological Products, John Jenkins, M.D. and Robert Meyer, M.D., will present the MDX platform at the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) Conference in Copenhagen, November 4.

Under the terms of the partnership, Greenleaf Health will pair its robust blend of technical expertise and vast institutional knowledge of the FDA process to deliver valuable insight and guidance for the MDX Platform.  Greenleaf’s team of experts will be led by three FDA leadership veterans: John Jenkins, M.D., former Director of the Office of New Drugs within the FDA’s Center for Drug Evaluation and Research; Robert Meyer, M.D., previously Director of FDA’s Office of Drug Evaluation II; and Karen Midthun, M.D., an infectious disease physician by training who most recently served as the Director of the FDA’s Center for Biologics Evaluation and Research (CBER).

Greenleaf’s Ronan said, “Trio’s MDX platform is a game-changer for the biopharmaceutical industry. The pairing of Greenleaf’s best in class regulatory expertise with Trio’s MDX Platform, creates an unmatched tool for improving patient outcomes and the safety of medicines.”

“The MDX platform is transformational for patients,” said Trio CEO, Brent Clough. “It can provide physicians unmatched insights into credible data sets validated by former FDA experts so that they can optimize patient care. In turn, the platform offers our life science customers best-in-class speed, data certainty, and unparalleled visibility across the clinical and commercial lifecycle. Such knowledge can be leveraged to support pre-and post-marketing activities to drive significant cost-savings and support greater patient outcomes.”

About Trio Health

Trio Health’s mission is to improve the quality of care in patient outcomes through coordinating the efforts of all patient care stakeholders. Their first-of-its-kind Multi-Disease Platform (MDX) tracks patients throughout the course of their treatment, giving pharmaceutical/biotechnology companies, specialty pharmacies and physicians access to information and opportunities that simply doesn’t exist anywhere else. Learn more at www.triohealth.com.

About Greenleaf

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.

With decades of experience in senior positions at the FDA and throughout industry, Greenleaf’s team of respected professionals brings unmatched expertise that companies need when navigating today’s evolving regulatory environment.  For more information on Greenleaf Health, visit www.greenleafhealth.com.

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