Speeding the Path to Regulatory Approval in the Era of Electronic Submissions

Newswise -- When a pharmaceutical company wants its new drug on the market, it must first submit mountains of paperwork to regulatory agencies like the US Food & Drug Administration (FDA)—most of it scientific articles describing the drug’s properties. Gathering these articles can be time-consuming, expensive and downright exhausting. And if the company opts to submit them all electronically, there’s another hurdle to clear: the regulatory agency wants all articles in the electronic Common Technical Document (eCTD) format. What’s an overworked pharma company staffer to do? Answer: turn to a dedicated professional document service for help. Such a service can speed the drug approval process and help companies save time and money.

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