We are a regulatory consulting company helping pharmaceutical and biotech companies with their regulatory filings of INDs, NDAs, and BLAs in major global markets including US, China, Europe and Japan. The majority of our lead principal consultants are recent ex-FDA experts in clinical, clinical pharmacology and CMC strategies, and they deliver deep real-world global regulatory affairs expertise and hands-on support to help bring to market biologic products, small molecule drugs, vaccines, and advanced therapies including gene and cell therapies. DataRevive is a Validant Company, which means we are part of a platform that gives you access to leading specialists in every facet of the drug product lifecycle, pre- and post-approval. Contact us at info@datarevive.us to learn more.