THinc is a company of regulatory affairs, medical writing, and submission services professionals with a proven track record of success in the pharmaceutical industry. THinc was established as a privately held consulting firm in 1995 to expedite the development and approval of new medicines. Our clientele range from emerging, privately held biopharmaceutical companies to Fortune 500 pharmaceutical companies.

 

Newsreel - What's New at THinc

NEW SERVICE - Submission Services

FDA's preferred method of secure submission of premarket and postmarket regulatory information for review is via the FDA Electronic Submissions Gateway (ESG). We provide full electronic submission services.

IMPORTANT DATES

May 5, 2017: New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs) must be submitted using electronic Common Technical Document (eCTD) format.

May 5, 2018: Commercial investigational New Drug Applications (INDs) and Master Files must be submitted using eCTD format.

 

 

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