Our Services

Consulting on development of CMC analytical methods for pharmaceutical substance and product

KMT gives advice for preparation of analytical method and validation from stage of
screening products to regulatory application.
KMT gives on-the-job training in the client's analysis facility if needed.

Consulting on regulatory application

KMT supports for Japanese Approval Application of Pharmaceutical Products.
KMT provides an idea to clients for preparation of answer to inquiries from PMDA.

In-country caretaker of APIs MF in Japan

KMT provides the following services:

Accreditation of Foreign Manufacturers
Drug Master File (MF) of APIs

Consulting on choosing Contract Laboratories

KMT gives supports for choosing Japanese analytical Laboratory, and contract
laboratories for pre-clinical and clinical studies.