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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

    On December 19, 2014, the Guideline "ICH Q3D - Elemental Impurities" was issued by the ICH, providing a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. The required comprehensive view on a products’ elemental impurities from all sides will cause major challenges for the pharmaceutical and chemical industry. In this webinar Dr. Dorothee Kriha will provide a close look at the core elements of the Guideline, outline challenges and give insight into what BASF as pharmaceutical ingredient supplier has done to help customers to comply with the new requirements for elemental impurities right from the start.