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 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
A gap analysis is a powerful tool that can be used to forecast a product’s success.. Learn More.
Meetings with Health Authorities
Formalized meetings with regulatory agencies are needed for both drugs.. Learn More.
Development of Technical and Regulatory Strategies
The level of inherent risk involved in the development of.. Learn More.