We help our clients with complex cross-border regulatory compliance procedures in Pharmaceuticals and medical products. We have an edge in providing strategic and operational services to obtain Japanese regulatory approval for pharmaceutical products.
We combine our knowledge of regulatory affairs with scientific acumen, strategic thinking and experience. We leverage our extensive network to provide our clients with a full range of regulatory services to support your business in Japan, India and other countries.
We can navigate the complex regulatory system for API or entry in to Japan by intermediates, as well as provide a wide range of services, including:
- Preparation of foreign manufacturer accreditation applications (FMA), GMP compliance inspection applications, inspection readiness, prior-approval Inspection and (PAI) onsite support.
- Preparation of Drug Master Files (DMFs) and acting as an In-Country Caretaker (ICC)
- Designated Marketing Authorization Holder (DMAH) service, preparation of Marketing Authorization Applications (MAA) and maintenance services (post-approval change management)
- CMC regulatory affairs consultancy, gap analysis & risk mitigation proposals
- Navigate reimbursement regulations and procedures
- Business Strategy
- Search for distributors and partnerships with shipping companies, make contracts with research organizations (CROs) for clinical studies
- Translation services (English, Japanese, Chinese)
- Industrial training