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    Pharmaceuticals Regulatory Services

    Regulatory Services

      We as a globally connected team of regulatory specialists support you as our customers in all aspects of regulatory affairs and provide your company with what is needed to succeed in the pharma market.

    Meet the needs of your business

      From advice and guidance, to full-spectrum regulatory support, our services focus on the following:

      • Worldwide registration and submission support, from accompanying documents to full dossiers
      • Life-cycle management of regulatory documents, always ensuring compliance
      • Tailored documents for target markets, specific products or applications
      • Consultancy and knowledge sharing, finding the best regulatory route to be successful or just keeping you up to date with regulatory matters

    Registration & Submission support

    Regulatory Documentation

    We provide all documents and key quality and regulatory information needed to support your existing and new business.


    ICH Q3D Guideline for Elemental Impurities

    Pharmaceutical Technology

    Managing Risk in a Complex Excipient Supply Chain