Strategy, Speed & Global Compliance
Regulatory success starts with smart planning. Our Regulatory Affairs team helps you navigate global and regional requirements to bring products to market faster — with confidence and clarity.
Why This Service Matters
From early-stage advice to post-approval support, regulatory expertise ensures your product moves smoothly through review processes across global markets.
Our Key Capabilities
End-to-end clinical trial management you can trust
📋 Regulatory Strategy
- Regulatory pathway assessment
- Risk analysis and gap assessment
- Scientific advice meeting support
- Orphan, Fast Track, Breakthrough strategies
🏢 Regulatory Submissions
- IND, CTA, ANDA, IMPD, 505(b)(2) filings
- Clinical trial applications & briefing documents
- eCTD publishing and lifecycle management
🧠 Ethics & Local Approvals
- Country-specific dossier preparation
- EC/IRB coordination
- Import/export license management
📦 Post-Approval Support
- Dossier updates and renewals
- Labeling and CMC support
- PV system setup and variations
🩺 Therapeutic Area Expertise
- Oncology
- CNS & Psychiatry
- Infectious Diseases
- Cardiometabolic Disorders
- Rare & Orphan Diseases
👥 Flexible Resourcing with FSP
- Clinical Project Managers
- Regional or National CRAs
- Clinical Trial Assistants & Document Specialists
- Regulatory Coordinators