New Services: On-Site Compliance Assessments, Remediation, Inspection
WASHINGTON–(BUSINESS WIRE)–Greenleaf Health, Inc., a leading Food and Drug Administration
regulatory consulting firm, 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.
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 &
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
For more information on Greenleaf’s comprehensive compliance services,
Greenleaf Health, Inc.