The ever-changing path of achieving regulatory clearance can be challenging. Through collaboration and trusted consultation, BLA Regulatory will function as an extension of your team, guiding you through every step of the regulatory process and creating a tailored end-to-end approach depending on your product and your company’s individual needs.
With experience of more than 300 INDs and 50 marketing applications, our team is a balanced combination of FDA-experienced experts, industry regulatory leaders, and professionals with local and global regulations expertise.
We are grateful for our partners at BLA Regulatory. This is a team with great depth of subject matter expertise. They delivered a high-quality work product on time and helped steward our team through a successful pre-IND FDA interaction for an innovative pivotal trial for rare genetic pediatric onset or congenital disorders.” ----- Topher Brooke, Co-Founder