|Date||Date of Registration : Jul 22, 2010
Date of Revision : Jul 29, 2018
|Country / Area||Tokyo, Japan|
0403 Pharmaceutical materials, pharmaceutical preparation(including biochemicals)
5404 Various booking and arrangement businesses
|Target Country / Area||All Countries / Areas|
*Attention: JETRO shall not take any responsibility for the contents provided by users. Please take note of the fact that JETRO leaves the exactness and reliability of the contents to users' judgment.
Japan Drug Master File (DMF) Registration Support Services
<< DESCRIPTION >>
We support the work of drug master file (DMF); review of related documents/materials, entering data into XML development tools, printing, developing indexes, filing of CTN related documents, preparation of CD-Rs, and application to PMDA in Japan.
*Features of Our Service
Our company is a drug-development consultancy, with professionals specializing in both clinical (including pharmaceutical regulation) and non-clinical drug development (including pharmacology toxicology) in Japan.
Our services include strategic development for drugs and foods with expertise in clinical development, regulatory strategy, regulatory operations (submissions), pharmaceutical development, formulation, medical writing, clinical trial notification, In Country Clinical Care- taker (ICCC), drug master file (DMF), and marketing researches.
- Pharmaceutical regulatory affairs expertise
- Review of development plan Timeline, budget, personnel plan, derivation, etc.
- Development of health food and food additive
- Import procedure (Investigational Products, foods)
- Establishment of the company structure for drug development
- Formulation of medicine and active pharmaceutical ingredients (API).
- Drug Master File (DMF).
- Generic products in Japan into the European Union market and for EMA works.
- Accommodation to the authorities
Please refer to our website for details.
*Examples of Fees
We accept your price consultation.
We have application experiences.
Tokyo, JapanJul 22, 2010 RegistrationJul 29, 2018 Revision
Total Sum of CONTACT Received : 10