In chemistry, manufacturing, and controls (CMC) regulatory writing, there is a difference in the level of detail required for New Drug Applications (NDAs) and Biologic License Application (BLAs) supporting different types of products. The expectations tend to diminish as time elapses and the regulatory authority becomes more familiar with a specific type of medicinal product. … Continued
Meet Rachel Bombara, Sr. Regulatory Operations Specialist at Certara. In this brief video Rachel shares how she manages tight deadlines and how she leverages technology to support her daily submission work.
Regulatory writers lead the development of high-quality regulatory documents by working incollaboration with colleagues across multiple functions. Document development is a multistep processwith the regulatory writer acting as project leader. This article describes each of the stages of theprocess and suggests best practices for achieving timely project completion and document delivery.
Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory Committee meeting that took place on 2021年4月15日 was not any different. The agenda included discussion of a biologics license application (BLA) for donislecel (purified allogeneic deceased donor pancreas derived Islets of Langerhans) for the treatment of brittle Type … Continued
Expands global reach and deepens regulatory expertise PRINCETON, NJ.— 2021年6月10日– Certara, Inc., the global leader in biosimulation, today announced the acquisition of Insight Medical Writing, based in Oxford in the United Kingdom. Financial terms of the transaction were not disclosed. Founded in 2002, Insight Medical Writing offers regulatory services and medical writing. Its … Continued
