Regulatory Affairs

One of the biggest mistakes a company can make when entering the pharmaceutical market is believing they can shortcut the process or negotiate with regulatory bodies in the EU, Canada, the USA, or Japan on their own.  There are many detailed steps involved in the process, and even minor errors can slow or totally derail an otherwise promising drug development program. ICCI’s regulatory affairs experts can help you avoid costly missteps and inefficiencies. With in-depth knowledge of Good Agricultural Practice (GAP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP), and extensive experience with national and international government agencies that oversee pharmaceutical development, ICCI can offer you the best opportunity to succeed in bringing your product to market in a timely and efficient manner.

ICCI’s Regulatory Affairs Services can provide you with guidance on:

  1. Changes in regional, national, supranational and international legislation

  2. Legal and scientific requirements

  3. Strategic and technical aspects of regulatory procedures

  4. Communicating and negotiating with regulatory agencies to obtain market authorisation

  5. Collecting and evaluating scientific data


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ICCI Webinar "Introduction to Clinical Trials" with Dr. Martin Votava 27. 11. 2019

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