Regulatory Compliance Associates (RCA), a Nelson Labs company, along with Sterigenics and Nelson Labs, part of Sotera Health, offer an integrated suite…
Michelle Heiter, laboratory and quality control specialist, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company,…
Background An established pharmaceutical company with a strong background in biologics and biosimilars was preparing to enter Phase 3 clinical…
Background A pharmaceutical company preparing for product commercialization faced significant challenges in meeting FDA expectations. The organization lacked standard operating…
Background A life sciences company preparing for growth and regulatory scrutiny faced major deficiencies in its quality infrastructure. The organization…