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Product Description

GMP SERVICES: FDA/EU REGULATORY DOCUMENTATION, GMP TRAINING, QUALITY ASSURANCE US AGENT SERVICES Magid-Haffner Associates, Inc. has the capabilities to take a product from inception through development to USFDA approval. Magid-Haffner Associates, Inc. can act as liaison for your company with the USFDA by providing assistance with the submission of IND, NDA, ANDA and DMF documentation, attendance at USFDA presentation and review meetings, and expediting of the final approval of the drug products resulting in U.S. distribution. With our overseas offices, M.H.A. (UK) Ltd., located just outside Manchester,UK and Shanghai, PRC, we have the capability and expertise to meet with international regulatory agencies on behalf of our clients to help expedite product approvals or resolve regulatory issues. "Compliance should improve the overall operation, quality and efficiency of the operation while achieving compliance, and having a positive impact on the corporation's bottom line."