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SRK Consulting
Walkersville, Maryland, United States
- Ownership
- Private
- Development stage
- Other
01
Overview
SRK Consulting, LLC is a specialized life sciences consultancy focused on Chemistry, Manufacturing, and Controls (CMC) and regulatory affairs. Founded by Steven R. Koepke, the firm provides expert guidance on the development and regulatory submission of drugs, biologics, and medical devices, including combination products. Their services encompass the scientific management of CMC programs, GMP compliance assessments, and the preparation of FDA submissions such as INDs, NDAs, and ANDAs. The company is headquartered in Walkersville, Maryland, and serves a global clientele in the pharmaceutical and biotechnology industries.
- Modalities
- Small moleculeBiologicDevice
- Industry
- Consulting
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