Pharmaceutical Regulatory Approval and Development Strategy Consulting
From pharmaceuticals, botanical drugs, generics, and biologics to advanced biopharmaceuticals, Meditip provides regulatory approval and development strategy consulting optimized for each product's characteristics and development stage.
Regulatory Approval Consulting
From customized strategy development tailored to product characteristics and approval stage to application preparation, MFDS response, and post-approval management, we provide expert support across the entire pharmaceutical regulatory approval process.
Pharmaceuticals · Botanical Drugs · Generics
Key Services
- Regulatory Approval Consulting for New Drugs, Data-Submission Drugs, and Herbal (Oriental Medicine) Preparations
- MFDS Liaison and Preliminary Review / Preliminary Consultation
- Pharmacovigilance
- Approval Details (Manufacturing Method, Separate Specifications, Provisional Standards) / CTD / RMP Preparation / GMP Review
- NDA / IND Strategy and Application Preparation
- Drug Master File Registration (DMF)
- Generic Product Approval (Notification) and Change Management
- Change Approval and Maintenance
- CMC / GMP Regulatory Approval Consulting
Biologics · Advanced Biopharmaceuticals · Biosimilars
Key Services
- Regulatory Approval Consulting for Cell Therapy / Gene Therapy Products
- CMC / GMP Regulatory Approval Consulting
- Regulatory Approval Consulting for Vaccines / Blood Products / Live Biotherapeutic Products
- Approval Details (Manufacturing Method, Separate Specifications, Provisional Standards) / CTD / RMP Preparation / GMP Review
- Regulatory Approval Consulting for Advanced Biopharmaceuticals and Advanced Regenerative Medicine
- MFDS Liaison and Preliminary Review / Preliminary Consultation
- Biosimilar Product Approval and Change Management
- Change Approval and Maintenance
- BLA / IND Regulatory Approval Consulting
Quasi-drugs
Key Services
- Quasi-drug Product Approval (Notification)
- Change Approval and Maintenance
Development Strategy Consulting / Training Support
From early-stage development strategy development, Gap Analysis, and Due Diligence to CMC, CDMO, and CTD training support, we provide successful direction across the entire product development lifecycle.
Key Services
- Full-lifecycle Strategy Development for Pharmaceutical Development
- CDMO Operation Consulting
- Non-clinical / Clinical Integrated Development Consulting
- Regulatory Approval and Bridging Strategy Development
- Gap Analysis
- CTD Preparation Training
- Due Diligence Consulting
- Practical Regulatory Approval Training Program
- CMC Strategy Consulting