Regulatory Services
We help you navigate CDSCO, USFDA, EMA, and other regulatory pathways to get your drug approved and on the market.
Overview
Regulatory strategy is about knowing what data you need, how to present it, and when to engage with health authorities. We've prepared IND applications, NDA submissions, and marketing authorization applications across multiple regions. Our team knows the regulations and has relationships with reviewers that help move applications through the system.
What We Do
Developing regulatory strategies for 505(b)(2) applications and orphan drug designations
Compiling IND packages including Form FDA 1571, investigator brochures, and CMC sections
Preparing responses to complete response letters and information requests
Submitting applications to institutional ethics committees and obtaining approvals
Managing post-approval commitments and annual reports to health authorities
Why Work With Us
Our regulatory team includes former FDA and EMA reviewers
We've successfully navigated accelerated approval pathways and breakthrough designations
Strong track record of first-cycle approvals without major deficiencies
Ready to Get Started?
Let's discuss how we can support your regulatory services needs.