Our services
Regulatory Affairs
Regulatory requirements shape every stage of development. Our regulatory team guides you from early strategy through approval and post-approval maintenance, across multiple authorities.
Services
- Regulatory strategy and pathway assessment
- Pre-IND / scientific advice meeting preparation
- IND, CTA and clinical trial application submissions
- Gap analysis of existing dossiers
- CTD / eCTD dossier compilation
- Marketing authorization applications
- Post-approval variations and renewals
- Labelling and artwork review
Authorities We Work With
- US FDA
- EMA and EU national authorities
- UK MHRA
- CDSCO (India)
- WHO prequalification
Let’s work together
Map your regulatory pathway with our team.
Tell us about your program and our experts will get back to you with a tailored approach and proposal.