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INTERNATIONAL REGULATORY BUSINESS CONSULTANTS, L.L.C.

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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

 

 

Annual Newsletter  -  January 2008

 

It's the time of the year again to wish you and your family a very Happy and Healthy New Year 2008!  I hope that you enjoyed the holiday season.

 

As it has been my practice, I am highlighting some of the more significant changes that have been occurring in the food and drug industry and that should be monitored in the upcoming year.  If you would like information or assistance on any of these or other regulatory and compliance issues, you can take the opportunity to contact me.

 

bullet Marketing unapproved drugs, ie. DESI/legacy/"grandfather" drugs
bullet Importation of foreign manufactured APIs and pharmaceutical products
bullet Safety of imported foods and drugs, especially regarding counterfeiting
bullet Growth of Indian and Chinese pharmaceutical companies and their influence in the marketplace, for APIs and drug products
bullet Acquisitions and mergers in Europe and the U.S.
bullet Drug safety/Adverse Drug Experience reporting
bullet Post-marketing/promotion practices
bullet Good marketing/promotion practices
bullet API and drug product plant inspections based on risk-analysis
bullet CGMP regulations for dietary ingredients and dietary supplements
bullet Plant inspections for manufacturers of dietary supplements
bullet Generic (follow-on) biologic products regulatory approval process
bullet New and generic drug products and Drug Master File submissions following the guideline ICH M4 The Common Technical Document (CTD)
bullet Preparation of Development Reports following Quality by Design (QbD) and guideline ICH Q8 Pharmaceutical Development
bullet Corporate procedures to follow guidelines ICH Q9 Quality Risk Management and Q10 Pharmaceutical Quality System
bullet Patent system issues including brand product life cycle extensions
bullet Streamlining the drug approval process

 

The world continues to evolve constantly - some changes helpful and some complex - with respect to regulations and requirements for health care products.  It is in our best interest to stay focused on the development of change in order to maintain our high standards for quality and reliability and provide continual business growth.

 

 

 
 

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