BLA Regulatory provides comprehensive strategy and operations services to guide you through every step of the regulatory process. We do this by creating a tailored end-to-end approach based on your product and company needs. Our goal is to help move your product efficiently through the drug development cycle.
Our scope of services can start from product research, nonclinical, and clinical development, right up to the submission, approval, and the maintenance stage. Throughout the process, as your U.S. FDA Agent, our regulatory affairs specialists can facilitate Pre-IND, pre or end-of-phase, and advisory meetings with the regulatory agencies. Our approach emphasizes building a solid IND/CTA strategy with NDA/BLA in sight. With deep industry expertise and regulatory intelligence, BLA translates regulatory requirements into workable plans throughout the product development cycle.
BLA functions as an extension of your internal team. We leverage our strengths and experience to ensure compliance of your product development and marketing program through the services we provide.