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.
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.
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.
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.