BLA Regulatory is a highly experienced biopharmaceutical consulting company based in Gaithersburg, MD. With a team of FDA-experienced experts, industry regulatory leaders, and professionals with local and global regulations expertise, they offer comprehensive regulatory services from strategy to execution. Their efficient processes management and extensive experience in INDs and marketing applications make them a trusted partner for companies looking to navigate the complex world of global regulatory requirements.
With a focus on major global markets including the US, Europe, Australia, Latin America, China, and Japan, BLA Regulatory provides services such as gap analysis, health authority meetings, IND filing maintenance, leading PI recruitment, U.S. agent representation, clinical trials registration, strategy development, medical writing, BLA and NDA filing maintenance, eCTD publishing, submission expedited regulatory programs, medical device consulting, medical device applications, and medical device reimbursement services. Their commitment to helping advance drugs around the globe is evident in their track record of successful collaborations and testimonials from satisfied clients.
Generated from the website