BLA Regulatory Advantages:
- Highly Experienced Regulatory Consultants from Industry and Regulatory Agency.
- Comprehensive Regulatory Services: from strategy to execution.
- Covers major global markets: US, Europe, Australia, Latin America, China & Japan.
- Efficient Processes Management.
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.
Years Combined Experience
We were looking for an experienced regulatory consulting company and BLA Regulatory more than delivered. The experts at BLA Regulatory worked as part of our team and took the time to understand our specific needs and goals. They promptly answered our questions and provided guidance on our biological drug candidate. BLA Regulatory leveraged its strength and expertise from both of FDA and industry experiences to assure the project successfully moved to a first-in-human clinical trial stage. " ---- Wenzhi Tian, MD, Chairman and CEO, ImmuneOnco Biopharmaceuticals
We are very pleased to work together with the BLA Regulatory team and found their professional and cooperative team experiences highly valuable for us. We are delighted to work as a team to obtain FDA approval for the Phase 1b/2 clinical trial of chiauranib for SCLC in the United States, based on the efficacy and safety data from early-stage clinical studies in China." ---- Dr. Lu Xianping, Chairman & CEO
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