Core Services
We provide end-to-end regulatory services:
- Develop innovative regulatory strategies for efficient drug registration
- Health authority consultation
- Advisory committee meetings with KOLs/SME
- We can be the in-country license holder—clinical trials or MAH
- Clinical study design for MRCT, regional or local registration studies
- Plant/site registration
- Advance regulatory policy and advocacy
- Regulatory intelligence
- Pharmacovigilance and drug safety
Expanded Services
Through our extensive in-country and regional network we can facilitate introductions with well-reputed local CROs, vendors and experts
- Regulatory Operations (e.g., medical writing, submissions, publishing, translation)
- Pricing & Reimbursement
- Legal Advice
- Partnerships and Joint Ventures
- Manufacturing/CDMO
- Third-party Logistics
- Patient Access
- Preclinical Research
- Product Launch Strategies
- Help establish new country offices
- RWE and Commercial insights
- Facilitate local partnerships for commercialization/licensing
- Create a regional presence through the innovative “hub&spoke” FSP model.
