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What we do

We work with marketing, regulatory, scientific departments and management on strategy for development or switch of OTC medicines, supplements and toiletries, with specialisation in the European area.

We also act as scientific and regulatory consultants for smaller companies and business development groups.




Regulatory and Scientific Affairs a Specialty. Provides advice on:

  • Switching
  • Product regulatory strategy in Europe
  • Review and direction of drug registration submissions in Europe including Mutual Recognition Procedure
  • Review of and assistance in drug and cosmetic advertising claims and their approval by appropriate agencies in each country, where required
  • Review of labelling for compliance with E.U. and national requirements
  • Design and direction of clinical studies for registration and to support claims for OTC medicines and toiletries
  • Evaluation and assistance on product claims and claim support
  • Bioequivalence/Bioavailablity. Consultation on need and obtaining the data if necessary
  • Clinical Studies - Registration and Marketing Support, Consumer Evaluation User studies to provide guidance during the development of OTC medicines and toiletries



Provides for the OTC and Cosmetic Industries expert assistance in:
  • Product Safety
  • Evaluation of formulas for human safety
  • Design and direction of adequate safety studies and advice on European and National requirements



External Relations issues
  • Evaluation of product safety according to EU guidelines
  • Clinical evaluation of products
  • Proof of Claims
  • New Product Development Programs
  • Regulatory Affairs/Registration and Strategy


Consumer Evaluation
  • User studies to provide guidance during the development of OTC medicines and toiletries




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