We assist with agency reviewers and help gain valuable insight into the agency’s expectations specific to your product. Pharmatech’s extensive experience with multiple FDA divisions within CDER, CBER, and CDRH, as well as international regulatory bodies (EMA, MHRA, PMDA, ANVISA, TGA, NMPA) facilitate successful interactions with health authorities. We conduct health authority meetings to ensure productive outcomes. Our experienced team knows when to recommend meetings, prepares documentation, coaches individual presenters, compiles meeting outcomes, and communicates results. Our comprehensive services ensure that regulatory strategies are revised based on health authorities’ suggestions.
Prepare for health authority interactions with valuable insight into the agency’s expectations specific to your product. Contact us for advice.
Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.
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