We, Pharma Planning Co., Ltd., will provide support from experts in development and pharmaceutical affairs in response to requests from customers.
1.Support for the development of drug
We will support at numerous points in the development schedule considered by the customer.
- Construction of a schedule for preparing documents necessary for application
- Investigation of related technical information and patent
- Confirmation of compliance of development data prepared to the pharmaceutical affairs regulations in Japan
- Support for preparation of CTD
- Introduction of contract manufacturers
- Introduction of other API manufacturers
- Support for planning various validations
- Advice to inquiries from regulatory authorities
- Examination of the feasibility of licensing-out to overseas and investigation of licensees
2.Support for the development of APIs
We will provide support at numerous points to customers who wish to utilize their core technologies in the pharmaceutical field and to manufacturers of intermediates.
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Construction of a schedule for preparing documents necessary for application and business strategy (target areas, tripartite harmonization, etc.)
- Investigation of related technical information and patent
- Confirmation of compliance of development data prepared to the pharmaceutical affairs regulations in Japan
- Support for construction of manufacturing facilities for tripartite-harmonized APIs (including API for investigational products)
- CTDの作成支援
- Support for preparation of CTD
- Support for planning various validations
- Advice to inquiries from regulatory authorities
- Provision of know-how for development
3.Support for the development of quasi-drugs
We will provide support at numerous points in the development schedule considered by the customer.
- Construction of a schedule for preparing documents necessary for application
- Investigation of related technical information and patent
- Support for preparation of CTD
- Introduction of contract manufacturers
- Support for planning various validations
- Advice to inquiries from regulatory authorities
4.Support for master file registration
Inspection of master file (MF) registration and drug marketing approval
We will inspect consistency of the actual status of manufacturing instructions and records and testing instructions and records with the approved matters from the perspective of a third party.
- Support for preparing data for application of MF
- Support for confirmation of consistency between CTD and FD application documents
5.Support for pharmaceutical affairs investigations
During overseas development of pharmaceutical products, APIs, excipients, materials, and so on, we will investigate information on regulatory matters in various countries that customers wish to know in cooperation with our overseas partner companies.
We will also advise business strategies and responses to PMDA to the customers who set out to launch a product in the Japanese market.