Product Development Services
From Medical Products Regulatory Services
Strategic Planning – Develop approval strategies including Chemistry Manufacturing and Controls (CMC) and non-clinical and clinical programs. FDA Liaison – Provide guidance and/or serve as a direct liaison with the FDA for the coordination of Prescription Drug User Fee Act meetings. Non-clinical Regulatory Support – Manage Investigational New Drug Applications’ toxicity studies, associated non-clinical safety studies, and biological activity programs to support clinical investigations and marketing authorization. Clinical Regulatory Support – Develop clinical investigations to establish safety, proof-of-concept, and efficacy sufficient to support marketing authorization.
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