The Client is a Hong Kong based pharmaceutical company which is focuses on developing, manufacturing of prescription, OTC drug, functional food, beverages, health supplements and personal care items. They were in a process of developing a generic product (and hence needed support for ANDA submission along with US local agent who can respond to USFDA queries.
GRP has significant experience in handling generic submissions within USFDA. GRP did a thorough planning of each steps considering the timelines the client was aiming the launch. GRP provided comprehensive inputs to Client to enable its successful registration in USA.
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How FDA Defines Substantial Equivalence to Predicate Devices