Cobridge provides consulting services and dossier preparation from a strong footing in science-based regulatory strategic thinking.

Our consultants have hands-on experience in pharmaceutics, and preclinical and clinical development of medical products both in Japan and overseas. Consulting services that we offer revolve around a sound regulatory strategy developed to bring the medical product to market in Japan by the quickest and most effective path to ministry approval.

We understand the transition of dossiers from products brought to market first overseas and then to Japan, and have experience in the preparation of Japanese registration documents from North American and European dossiers.
We examine a product's existing preclinical and clinical data to design a regulatory strategy for the best path to Japanese MHLW or PMDA approval. Clients with regulatory affairs functions in their local offices have benefited from seminars conducted by Cobridge to acquaint their Japanese colleagues with the regulatory environment in the home-office's country.

1. Settling on strategy for product development in Japan
2. Consultation for regulatory approval and preparation of documents
3. Preparation of documents on product's manufacturing and quality control
4. Planning and project management of quality control testing
5. Project management and preparation documents for preclinical studies
6. Planning and preparation of protocol design for clinical studies
7. Negotiation with MHLW and PMDA
8. Negotiation and correspondence with foreign manufacturers
9. Settling on strategy for drug reimbursement pricing
10. Preparation of Drug Master File (DMF)