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Pharmaceutical Licensing
Market entry for pharmaceuticals, from start to finish
From small molecules to advanced biologics, we consult across the full MFDS regulatory lifecycle — pre-submission strategy through post-market surveillance.
What we offer
Pharmaceutical Licensing
Small Molecule
NDA, generic and improved drugs — dossier preparation and MFDS submission.
Natural Products
Safety and efficacy evaluation and licensing advisory for herbal medicines.
Quasi-drugs
Product notification and registration for toothpaste, mouthwash, ointments.
Biologics
CMC, non-clinical, and clinical dossier preparation for biologics and biosimilars.
Cell & Gene Therapy
Regulatory strategy under the Korea Advanced Biopharmaceuticals Act.
Post-market
PMS, re-examination, PSUR and lifecycle safety surveillance.
Regulatory Process
A 4-stage standard process MEDISOL walks through with you
Pre-consultation
Product classification, regulatory pathway, and dossier package definition.
Dossier Preparation
Integrated CMC, non-clinical and clinical documentation.
MFDS Submission
IND/NDA/BLA filing, response to deficiencies, review meetings.
Post-market
PMS, re-examination, 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.