Greenleaf Health today announced the firm has expanded its portfolio of services to include comprehensive on-site compliance assessments, remediation, and inspection readiness.  By expanding Greenleaf’s compliance service portfolio, the firm is now capable of providing a full-service experience for companies navigating today’s evolving FDA regulatory environment.

“Greenleaf has a proven track record of providing excellent services to life science companies seeking strategic and technical expertise to strengthen their quality management systems and guide them through challenging quality and compliance matters,” said John Taylor, President and Principal, Compliance and Regulatory Affairs.

Comprehensive Capabilities

Greenleaf’s team of experts draws on a combined total of more than 200 years of FDA experience.  With decades of experience in senior positions across the FDA and throughout industry, members of the Greenleaf team work cross-functionally to provide full-service support to clients.

In addition to Greenleaf’s core regulatory consulting services, the firm’s capabilities now include:

  • Inspection Readiness:  An FDA inspection is a critical moment for any FDA-regulated company. Greenleaf experts strengthen clients’ readiness for FDA pre-approval and surveillance inspections through training, mentoring, audits and mock inspections.
  • Compliance Assessments: Greenleaf works with life science firms to evaluate and strengthen compliance functions with an eye towards optimizing processes, mitigating risks, and creating a culture of compliance.  The Greenleaf team performs objective audits and assessments of a clients’ operations to identify strengths and areas of needed improvement, while continuing to meet business objectives.
  • Compliance Remediation:  Greenleaf’s experts bring an unmatched level of experience and insight when guiding companies along the remediation pathway. Greenleaf’s services address the complete scope of remediation, from acute enforcement actions, to strategic development and implementation of remediation plans.

Unmatched Regulatory Experience

Members of the firm’s Product Quality, Manufacturing, and Compliance Team include former leaders and regulatory experts from the FDA, Capitol Hill, top global pharmaceutical companies, leading law firms and the top U.S. biotechnology trade organization.  Greenleaf’s robust blend of regulatory expertise and FDA institutional knowledge allows the firm to provide unmatched regulatory guidance.

Greenleaf’s wealth of experience will be complimented by a network of advisors with specialized technical expertise.  To further enhance the firm’s robust compliance services, Greenleaf has developed an Independent Contractor (IC) Network comprised of respected professionals capable of being deployed to provide on-site services at firms that manufacture FDA-regulated products.

The combined knowledge and extensive experience of the collective Greenleaf team allows the firm to offer support to clients on a wide array of regulatory matters, from proactive inspection readiness projects to strategic advising on acute enforcement actions to global assessments and remediation of corporate-wide compliance matters.

About the Product Quality, Manufacturing & Compliance Team

Greenleaf’s Product Quality, Manufacturing, and Compliance Team delivers full-service regulatory guidance.  In addition to the expanded remediation, auditing and compliance assessment services, the team responds to clients’ needs via the following core consulting services:

  • Consultation, Training & Regulatory Guidance: Greenleaf provides corporate insight and guidance on regulatory matters that impact companies manufacturing FDA-regulated products.  The Greenleaf team regularly partners with companies to deliver strategic and technical guidance; help achieve business and regulatory objectives; and develop and deliver training in a variety of regulatory areas.
  • FDA Communications: Greenleaf’s best-in-class experts bring value to any communication with the FDA.  Greenleaf’s communication services include analysis and response recommendations for formal regulatory communication, compliance actions and regulatory correspondence, as well as preparation and support for FDA meetings, correspondence, and other regulatory interactions.
  • Advisory Services: Greenleaf understands the complex environment within which life science transactions take place.  Members of the Product Quality, Manufacturing, and Compliance Team frequently advise investors to evaluate potential issues and regulatory risks that may be identified during life science transactions.

About Greenleaf Health

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

For more information on Greenleaf’s comprehensive compliance services, visit Greenleaf’s Compliance Services.