Pharmatech offers best-in-class regulatory expertise to ensure that your submissions and agency negotiations proceed as smoothly and effectively as possible. We have experience in each therapeutic area with marketing authorization applications across the globe. In addition to authoring CTD sections, our staff is also experienced at crafting responses to information requests (IRs) from health authorities to address their clinical, CMC, and non-clinical concerns. For markets that require electronic submissions, Pharmatech can prepare and submit your documents in electronic format (eCTD).
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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