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Kevin Randall is President & CEO
of GlobalReg Compliance Associates, Inc.
Kevin has vigorously pursued the highest
levels of excellence in regulatory affairs
and quality systems since entering the profession
in 1995. Since that time Kevin has
directed and supported the regulatory and
quality functions of both start-up companies
and mature companies with annual revenues
exceeding 250 million dollars. Active
in the Regulatory Affairs Professional Society
(RAPS) at both the local and national level,
Kevin is always seeking to improve the quality
of GlobalReg’s services. Kevin has
spoken and taught at local and national
RAPS conferences and holds the U.S. Regulatory
Affairs Certification (RAC). Kevin
was also one of the first 22 people in the
world to achieve the European Union RAC.
The Associates at
GlobalReg average over ten years of experience
each, and have an established track record
of:
- Managing regulatory
crises including robust FDA-483’s, FDA
Warning Letters, and product recalls,
thereby restoring reputable standing
with FDA regulators.
- Developing
submissions in cost effective fashion
and achieving timely, predictable FDA
approval, minimizing the crippling delays
and frustrating expense of FDA requests
for Additional Information.
- Speaking/teaching
at national and local conferences to
present practical, “best-practices”
insight and regulatory interpretations.
- Valuing the
interrelationship between successful
business enterprise and effective regulatory
and quality systems.
- Transforming
ailing quality systems into sustainable
business assets by incorporating “best-practices”
solutions which positively impact the
bottom line
- Building strong,
motivated cross-functional teams to
implement and maintain process-based
quality systems.
- Using superior
knowledge and understanding of regulatory
law to develop practical and manageable
compliance solutions.
- Demystifying
FDA and FTC requirements for advertising
and promotion of regulated products.
Our
Mission
Our
Accomplishments
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