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.