Japan’s PMDA
GRP Japan: Your Trusted Partner for Market Entry and Compliance
Since 2016, Global Regulatory Partners Japan (GRP-Japan), a subsidiary of the GRP Group, has been assisting pharmaceutical and biotech manufacturers in navigating Japan’s highly regulated market.
GRP-Japan specializes in regulatory support for the market entry of orphan drugs, innovative products, and biologics, ensuring full compliance with the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW). As a licensed Market Authorization Holder (MAH), GRP-Japan provides end-to-end regulatory solutions, including compliance management, product registration, approval, and commercialization.
With extensive expertise in Japan’s complex regulatory landscape, GRP-Japan ensures a smooth and efficient market entry process. Our comprehensive regulatory services cover a broad range of health products, including pharmaceuticals, biologics, high-risk medical devices, and cosmetics.
Why Choose GRP-Japan?
- Product Hosting – GRP-Japan is licensed by PMDA to act as your MAH partner.
- Expert Bilingual Team – Our Tokyo-based regulatory experts ensure full compliance with PMDA and MHLW requirements while maintaining vigilance and transparency.
- Licensed Warehousing – GRP-Japan operates GMP- and ISO-certified warehouses for pharmaceuticals, biologics, and high-risk medical devices.
- Authorized Importer – As a licensed MAH, GRP-Japan legally imports and facilitates customs clearance for your products in Japan.
- Distribution & Commercialization – Comprehensive support for bringing products to market.
- Post-market Surveillance – As an MAH, GRP-Japan ensures compliance, quality, and safety for all products under our management in Japan.
Please visit GRP's newly launched MAH website for the Japan Market
Pre-Market Services
- Regulatory Strategy & Compliance
- PMDA/MHLW Consultation Meetings : Prepare & submit meeting packages, Provide support during meetings to ensure productive outcomes, Draft meeting minutes and action plans.
- Accredited Foreign Manufacturer (FMA) Certification & Maintenance.
- Drug Master File (DMF) Submission for Active Pharmaceutical Ingredients (APIs)
- New Drug Application (NDA) Dossier Preparation & Submission
- Dossier Preparation in ICH CTD / JNDA Format
- CMC Documentation & GMP Compliance Support
- Translation of Submission Materials into Japanese
- Pre-NDA Consultation with PMDA
- Electronic & Physical NDA Submission to PMDA
Post-Market Services
- Product Price Application
- Importation Management
- Pharmaceutical Storage
- Product Release (QA)
- Regulatory Compliance & Risk Management
- Pharmacovigilance & Adverse Event Reporting
- Call Center & Medical Information Services
- Recall & Incident Management
- License Renewal & Regulatory Maintenance
- Regulatory Support for Product Lifecycle Management
Other Services:
- Market Authorization Transfer (MAT)
- Analytical Transfer
- Distribution
Navigating Japan’s complex regulatory landscape requires expertise and strategic planning. GRP-Japan provides tailored support to ensure a smooth and efficient pathway to market entry for your medical device or IVD.
Our Key Services
- MAH/DMAH Product Licensing – Designate GRP as your local Marketing Authorization Holder (MAH) or Designated MAH (DMAH) partner.
- Regulatory Intelligence & Compliance – Stay updated on Japan’s evolving regulations.
- Regulatory Strategy & Cost Optimization – Develop efficient, cost-effective registration pathways and proactively mitigate risks.
- Product Registration – Prepare and submit Technical Files/STED for PMDA submission and submit.
- PMDA Consultation Support – Navigate PMDA meetings with expert guidance.
- PMDA Communication – As MAH, GRP manages all regulatory interactions with PMDA.
- Post-Market Surveillance – Ensure compliance, safety, and quality within Japan.
- Medical Product Warehousing – GRP licenses for Class III & IV medical device storage.
- Distribution & Commercialization – Support for successful product launch and market expansion; distribution negotiations and contracts.
Our Services:
- MAH Services – Act as your official MAH in Japan, handling registration, compliance, and post-market activities.
- Regulatory Intelligence – Monitor PMDA/MHLW updates on cosmetic and quasi-drug regulations.
- Regulatory Strategy – Develop efficient registration pathways to reduce time and costs.
- Product Registration – Manage regulatory submissions for cosmetics.
- Packaging & Labeling Compliance – Ensure MHLW-compliant labels and claims.
- Formula Review – We review Cosmetic Formulas to ensure Japanese Compliance.
- Importation & Warehousing – Handle customs clearance, licensed storage, and product traceability.