Project Consulting Services
Japan PV/Drug Safety Consulting Services
DMP & DECCAN offers business expertise and industry knowledge through A Step-by-Step project consulting support to kick-start your Pharmacovigilance/Drug Safety 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.
Pharmacovigilance AE Case Management Services
Comprehensive AE Case
- ・Spontaneous Post-marketing Cases
- ・Clinical trial cases
- ・Regulatory Agency forwarded cases
- ・Literature cases
- ・Legal/Offlabel cases
- ・Case Intake/Triage
- ・Data Entry (DE) / Coding (MedDRAj)
- ・Quality Review/Check (QC)
- ・Case Assessment/Translation
- ・Case Report Preparation
- ・Percieve Ace/PV
- ・Homegrown Systems/Excel/XML, etc.
DMP & DECCAN has the capability to provide the necessary resources for Comprehensive AE Case Management of all serious and non-serious adverse event cases as requested by Sponsors, including but not limited to: spontaneous post-marketing cases, clinical trial cases, cases forwarded by the regulatory agencies, literature cases, and legal cases. DMP & DECCAN uses stringent metrics for the case processing team, which will be reviewed during the transition period.
AE Case Management Engagement Overview
Transition | Training | Go-live | Retrospective Review | Post Go-live
Central to this partnership approach are:
- Significant PV/Drug Safety Talent Recruitment Expertise in Japan: DMP & DECCAN is a Japan MHLW licensed recruitment agency solely dedicated to the Life Sciences industry in Japan. Our dedicated Talent Acquisition consultants with an average experience of over 15 years ensures qualified and experienced PV associates are recruited to Client PV project (s).
- Proven Case Study of setting up AE Case Management Business in Japan from Start to Go-Live to Ongoing Case Processing Project Management: This encompassing hands-on knowledge and expertise of addressing Japan PMDA specific J-GVP regulatory compliances. This includes preparing Vendor Qualification Audit Checklist, Drafting Project SOPs, Guiding Procedures for Self-Inspection and CAPA Management, setting up Applications and IT Infrastructure, recruiting AE Case Management specialists (Triage/DE/QC/PM/SCM/EM/MR) in Japan (onshore) and India (offshore).
- Strong Focus on Quality: Metrics-backed SLA’s governing all projects – contractually bound performance & quality
- Reduced Drug Safety Costs: DMP & DECCAN has Partnership with offshore (Bangalore, India) End-to-End Pharmacovigilance and Drug Safety solutions provider. Together we make PV simple and cost effective.
- Experienced Ramp-Up & Scalability: Access to Large resource pool of healthcare professionals fully trained on ARISg/j, ARGUSg/j, Perceive Ace/PV safety database, both in Japan and India; project team members subject to final approval by the Client. This allows for a quick and seamless transition to the DMP & DECCAN team.
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)
- Identifying 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