Regulatory affairs

Regulatory affairs is a term that includes a lot. But we dare say we cover most of what is included in the term as from the late development phase and onwards, for pharma products. We have highly experienced regulatory specialists who can act as your regulatory affairs department, or help with selected issues. For early development regulatory affairs, we collaborate with our brilliant colleagues within the CTR group.

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Regulatory CMC

Chemistry, manufacturing and control data, also known as the quality documentation is as important and extensive for all types of products and applications. We can help you with the writing of module 3 and the quality overall summary, with guideline interpretations and variations classifications. We can also help you in the communication with and coordination of contract manufacturing and development organisations (CMOs/CDOs).

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