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.
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
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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.Download area