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Pharmaceutical Licensing
Market entry for pharmaceuticals, from start to finish
From new drugs, supplementary-data drugs, and herbal preparations to advanced biologics and cell therapies — we handle every regulatory pathway (NDA, IND, CTD, DMF) together with MFDS liaison.
What we offer
Pharmaceutical Licensing
Pharmaceutical Licensing
NDA/IND filings and MFDS liaison for new drugs, supplementary-data drugs, and herbal preparations. Generic product approval (notification) and variations.
CMC · GMP Consulting
Safety/efficacy, specifications and test methods (CMC), and GMP consulting across full pharmaceutical development and clinical trials.
DMF · CTD · RMP
Drug Master File (DMF) registration, CTD and RMP authoring, MFDS pre-review processes.
Bridging Strategy · Training
Licensing and bridging strategy consulting. Practical training in CTD authoring methods.
Quasi-drugs
Product approval (notification) and variations for toothpaste, mouthwash, ointments, disinfectants, and similar quasi-drugs.
Biologics · Cell Therapy
Licensing for cell therapy, recombinant DNA, and gene therapy products. Biosimilar development and licensing. Vaccines, blood products, antitoxins, and other biological products.
Regulatory Process
Full-lifecycle pharmaceutical development and clinical advisory
Pre-submission Advisory
Product classification, regulatory pathway, dossier definition, and bridging strategy.
CMC · Clinical Dossier
Integrated CMC, non-clinical and clinical dossier authoring. DMF, CTD, and RMP preparation.
MFDS Submission
IND/NDA/BLA track-specific submission, pre-review utilization, deficiency response, and review negotiation.
Post-market
PMS, re-examination, periodic safety reporting (PSUR), advertising review, and full lifecycle support.
If the first step feels difficult
The first decision in regulatory consulting matters most. Book a free 30-minute consultation with MEDISOL to design the most efficient market entry path together.