Navigating global regulations is essential for clinical trials, drug development, and pharmaceutical manufacturing. Our Regulatory Affairs experts provide end-to-end support, ensuring compliance, minimizing delays, and securing timely approvals across all stages of product development and commercialization.
Our Core Services:
Regulatory Strategy & Planning
Tailored regulatory roadmaps for clinical trials, product registrations, and market expansions
Feasibility assessments for optimal approval pathways (new drugs, generics, biologics, medical devices)
Pre-submission meetings with health authorities (FDA, EMA, PMDA, NMPA, etc.)
Submissions & Approvals Management
End-to-end dossier preparation & submission (IND/IMPD, CTA, NDA/BLA/MAA, ANDA, DMF)
Clinical trial applications (CTA) and marketing authorization submissions (MAA, NDA, BLA)
Ethics Committee (EC) & IRB coordination for global trials
