Medical Product Regulatory Services
2 services found
by:Intertox, Inc. based inSeattle, WASHINGTON (USA)
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 ...
by:James Hutton Limited based inDundee, UNITED KINGDOM
James Hutton Limited is home to Mylnefield Lipid Analysis, a specialist lipid laboratory established at the James Hutton Institute in 1995 by Bill Christie and Frank Gunstone, renowned lipid analysis ...