{ Regulatory Affairs }
The DaVita Clinical Research (DCR) regulatory team has the expertise to provide both the strategic and tactical support you need for drug, biological, and medical device products in preclinical development through post-approval surveillance. Our services include strategic regulatory consulting, preparation of regulatory submissions, and intervention as a regulatory liaison.
Our knowledge of regulations and regulatory agencies in North America and Europe, as well as our understanding of global regulatory requirements and submission strategies, can help achieve clinical trial authorizations such as IND, CTA, and IDE, as well as marketing authorizations such as NDA and ANDA.
Regulatory services:
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Regulatory and submission strategy consulting
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Product development planning
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Regulatory liaison
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Investigator brochures
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Pharmacovigilance
