Newsletter

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.

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