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Regulatory Support

Active pharmaceutical ingredients, excipients and pharmaceutical raw materials are part of the challenge for our Regulatory Service department. To fulfill all of these requirements, we support the regulatory and quality related activities of the various business units. Specialists in all the main fields of interest are available to assist you with your specific questions or requirements.

  • Certification

    Certifications provided for aflatoxins, allergens, BSE/TSE, Halal and Kosher.
  • GMO

    Merck even goes beyond the legal requirements, making certificates available for products that are not yet on the EU's list. And we are able to do this because we are up-to-date on the latest - and upcoming - developments in the field of regulatory affairs.

    GMO Enduser Declaration Form

  • GMP and HACCP 

    As a manufacturer of medicinal products, active pharmaceutical substances, excipients, active cosmetic substances, food additives and other food ingredients, we operate according to recognized international quality standards and adhere to all relevant regulations.
  • International Regulations

    Merck complies with the industry standards set by authorities in the US, in Europe, in Japan and in other countries.
  • Professional Memberships

    By keeping our fingers on the pulse of regulatory developments, we help you make well-advised decisions on your next steps. You profit from our relationships developed through in-depth expertise built up over the years.
  • Quality Management

    You are in good hands when you rely on Merck's quality. We have been handling complexity in chemicals and pharmaceuticals for a long time – and you can rest assured that we have no intention of breaking with our tradition.
Your fast track through regulatory challenges. The new Emprove® program. Learn More

Your Fast Track Through Regulatory Challenges.
The Emprove® program.

Learn More

Globally Harmonized System

Labeling of chemicals

EU Chemical Regulation

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