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Regulatory support

Regulatory support for
pharmaceuticals and medical devices

In addition to product and service excellence, our customers can count on advice and hands-on support throughout the regulatory approval process to optimize time-to-market.

Our experience provides a major head start. Besides ensuring continuous surveillance of evolving global and local legislation, as well as regulatory and cGMP requirements, our regulatory support specialists also author and maintain worldwide registration documentation.

Regulatory services

  • REACH registration

  • Expertise in registration processes worldwide

  • Know-how in regional regulatory specifics

  • Proactive implementation of new regulatory requirements

  • Creation of Drug Master Files

  • Creation and maintenance of Certificates of Suitability

  • Consultancy in regulatory issues

  • Regulatory affairs services

onCare
SIGN IN TO OUR ONCARE WEB PORTAL

Register for our onCare web portal to get 24/7 access to standard regulatory documents (such as EIP product regulatory datasheets, summaries of safety data, storage stability data, reduced frequency testing data) online.

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Evonik Health Care