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.
INDs
Marketing Applications
Agency Meetings
Years Combined Experience
Testimonial
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
Chipscreen Biosciences
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
Rumpus Therapeutics
BLA Regulatory Spotlight
Regulatory Gap Analysis
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Meetings with Health Authorities
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Development of Technical and Regulatory Strategies
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