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MISSION STATEMENT
Providing scientific and regulatory
consultant services
to the global pharmaceutical,
dietary supplements and medical devices
and diagnostic products industries
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INTERNATIONAL
REGULATORY
BUSINESS
CONSULTANTS,
L.L.C. |
Ira R. Berry, President
January 2010
ANNUAL NEWSLETTER
It’s
another January and I wish you and your family a Very Happy and
Healthy New Year 2010! I hope that you enjoyed the holiday season
and we all look forward to a rewarding and positive new year.
Following are some of the more significant changes that have been
occurring in the food and drug industry and that should continue to
be tracked for regulatory compliance:
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Counterfeiting and importation of
foreign drugs – APIs and drug products
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Third party auditing of API and
drug product manufacturers
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Safety measures for control of
food and drug product quality
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API and drug product plant
inspections based on risk analysis
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Requirement for electronic
submissions of drug listing – establishments and products
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FDA opening permanent offices in
China, India, Europe and Latin America
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Growth of Indian and Chinese
pharmaceutical companies and their influence in the marketplace,
for APIs and drug products
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Revisions to drug CGMP
regulations and requirements – APIs & dosage forms
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Updated validation requirements
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CAPA (corrective and preventive
action) systems deficiencies – 483s, Warning Letters
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Corporate procedures to follow
guidelines ICH Q9 Quality Risk Management and Q10 Pharmaceutical
Quality System
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Increased FDA enforcement of
promotional materials regulatory compliance
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Safety of foreign drug clinical
trials
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Improving the regulatory process
for faster product approvals, ie, DMFs, ANDAs, NDAs
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Generic (follow-on or biosimilar)
biologic products regulatory approval process
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Marketing unapproved drugs, ie,
DESI/legacy/“grandfather” drugs
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Acquisitions and mergers
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Post-marketing surveillance,
safety reporting – pharmacovigilance plan
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CGMP regulations for dietary
ingredients and dietary supplements
Our
world will continue to change – some changes helpful and others
complex and even unanticipated – with respect to regulations and
requirements for health care products. Our mission is to stay
focused and keep current with these changes so as to maintain
quality standards and regulatory compliance.
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Providing scientific and regulatory consultant services
to the global pharmaceutical, nutritional and medical
devices and diagnostics products industries |
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2275 West County Line Road,
Suite 6 #324,
Jackson, New Jersey 08527
Phone:732-833-1666 Fax:732-833-4833
E-mail:
ira.berry@irb-c.com
Copyright © 2008 International Regulatory Business Consultants, L.L.C. |
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