Regulatory Expert Services
- ESG, CESP, EDQM and MHRA Gateway Setup
- ER (Establishment Registration), NDC (New Drug Code) XML submissions
- GDUFA and Drug Listing
- Prepare and Review Structural Product Labelling (SPL) for ANDA and NDA application
- Local Agent Service (US, EU, Canada, Jordan, South Africa, GCC and many more)
- QPPV Service and Pharmacovigilance
- Preparation and Review of information required for development of regulatory CMC
- Computer Systems Validation (CSV)
- US Agent Service