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Pharmacovigilance – Drug Application

Recently Federal Laws stated that “a drug should be the subjected to an approved marketing application earlier than it is transported or spread. Since promoter wants to ship this drug to different clinical investigators in various states, it should seek a release from that legal requirement.”

GAP has three complete NDA submissions. GAP adheres to the guidance, regulations, and the sponsor’s Standard Operating Procedures (SOPs) to effectively file your NDA. We are completely aware of NDA review principles, policies and procedures. GAP can also extend their support to the legal requirements of the NDA at all levels.

Contact us for more information.