Business-Alliance-Partnership –For the Life Sciences Industry 「MEDiTalent™」

Project Consulting Services

Japan Drug Safety (PV) Consulting Support

DMP & DECCAN offers business expertise and industry knowledge through A Step-by-Step project consulting support to kick-start your Pharmacovigilance (PV) Strategic Business Unit (SBU) in Japan in the following areas of expertise:

• Japan Pharmacovigilance Market Snapshot (Executive Report)
• Go-To-Market (GTM) strategy advisory
• Pre-Sales support
• Request for Proposal (RFP) writing in English and Japanese
• PV Capabilities Presentation Deck creation in English and Japanese
• Japan PMDA Regulatory specific E2B (R3) and Green Book (J-Items) AE Reporting Requirements guideline in English
• Bilingual (E-J) Concise Japanese PV Glossary (excel) for onshore/offshore AE Case Management team
• Service Supplier (PV Outsourcing Vendor) Qualification Audit checklist orientation
• J-GVP Quality Self-Inspection Implementation and CAPA management regulatory guideline training
• QC check of AE Case Management project related SOPs, PMP, BCP, SOW, SLAs.

Japan Regulatory Submission Support

DMP & DECCAN will act as a Single Point of Contact (SPOC) for providing local Regulatory Consulting support from time to time through our Partner Consultants (SMEs), local Regulatory Affairs Consulting firms and CRO partners, in areas of Drugs, Medical Devices, Cosmetics, Food & Dietary Supplements, Biotech, OTC and their registrations/submissions.

Our support includes but not limited to following:

• Pre-Sales support
• RFI/RFP documentation support
• Assisting Client teams for the Proposals/ Quotes of the service requested by end customers (service buyers)
• Support as License Holding/ Legal Representative – In-Country Clinical Caretaker (ICCC) and Designated Marketing Authorization Holder (DMAH)
• Identifying Distribution partners

Japan Business Matching Support

Using our Business-Alliance-Partnership engagement model, DMP & DECCAN will act as a Single Point of Contact (SPOC) for facilitating Business Matching Support for both Japanese and foreign Biotech companies seeking desired business partners for expansion in the following areas of activities:

• Joint Venture and M&A Partnership
• In-Licensing and Out-Licensing
• Joint Research and Development
• Manufacturing Service
• Sales of Reagents
• Product Licensing
• Technology Licensing
• Distributorship Agreement, Agency Agreement
• Testing Services