NDA & FDA Compliance Requirements: How Document Automation Software Can Help

With the innovation of new drugs and vaccines and their introduction to the market, pharmaceutical companies have to keep track of and efficiently manage the generation of large volumes of documents.

The innovation of new drugs and vaccines and their introduction into the market sees the generation of a large volume of documents. Pharmaceutical companies need ways to keep track of and efficiently manage these documents. Windward can help automate the document generation process.

FDA regulations compliance has become a necessary and lengthy aspect within the industry as it’s aimed at only promoting high quality, safe, and efficient drugs in the market (the application to the drug approval process by the FDA can take anywhere between 12-15 years). The fact that only around 10% of the drug applications got approved in the last three years and the average cost of introducing a new drug into the market was around $2.8 billion (in 2013) makes a serious case for getting it right the first time.

To ensure improved productivity and compliance with these regulations, pharmaceutical companies can take advantage of document automation systems like Windward. Windward can help generate thousands of documents in just a few clicks: fast and flawless!