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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 2012
ANNUAL NEWSLETTER
10th
Year Anniversary Issue
Another
year is moving ahead
and I wish you and your family a Very Happy and Healthy New Year
2012 and Holiday Season! I hope that you are enjoying the holidays
and we look forward to a successful new year.
Following are some of the
more significant issues that have been affecting the food and drug
industry and that should continue to be tracked for regulatory
compliance and corporate growth:
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Quality failures lead to FDA Warning letters
and recalls
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Quality systems management prevents regulatory pitfalls
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Regulatory compliance and quality improvement saves money
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Counterfeiting and importation of foreign drugs – APIs and drug
products
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Supply chain management
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Responsibility for CGMP audits
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CAPA
(corrective and preventive action) systems deficiencies – 483s,
Warning Letters
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API and drug product plant inspections based on risk analysis and
risk management
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Effective risk management programs
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Marketing unapproved uses of drug products
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Marketing unapproved drugs, ie, DESI/legacy/“grandfather” drugs
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Revisions to drug CGMP regulations and requirements – APIs & dosage
forms
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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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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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Post-marketing surveillance, safety reporting – pharmacovigilance
plan
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CGMP regulations for dietary ingredients and dietary supplements
The
pharmaceutical and health care industry faces continuous change –
that can offer challenges for improvement – with respect to
regulations and requirements for compliance. Our goal is to remain
current with these changes – to preserve our quality standards,
regulatory compliance and introduce new products to improve consumer
health at reasonable cost.
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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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