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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

 

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:

 

  • Counterfeiting and importation of foreign drugs – APIs and drug products
  • Third party auditing of API and drug product manufacturers
  • Safety measures for control of food and drug product quality
  • API and drug product plant inspections based on risk analysis
  • Requirement for electronic submissions of drug listing – establishments and products
  • FDA opening permanent offices in China, India, Europe and Latin America
  • Growth of Indian and Chinese pharmaceutical companies and their influence in the marketplace, for APIs and drug products
  • Revisions to drug CGMP regulations and requirements – APIs & dosage forms
  • Updated validation requirements
  • CAPA (corrective and preventive action) systems deficiencies – 483s, Warning Letters
  • Corporate procedures to follow guidelines ICH Q9 Quality Risk Management and Q10 Pharmaceutical Quality System
  • Increased FDA enforcement of promotional materials regulatory compliance
  • Safety of foreign drug clinical trials
  • Improving the regulatory process for faster product approvals, ie, DMFs, ANDAs, NDAs
  • Generic (follow-on or biosimilar) biologic products regulatory approval process
  • Marketing unapproved drugs, ie, DESI/legacy/“grandfather” drugs
  • Acquisitions and mergers
  • Post-marketing surveillance, safety reporting – pharmacovigilance plan
  • 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.

 

 

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
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