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JAPANESE

Comprehensive Consulting for Drug Development (PMDA, FDA, EMA)

Proposal Number : 1120580       Provide business supports
Date Date of Registration : Oct 14, 2010
Date of Revision : Oct 14, 2010
Country / AreaTokyo, Japan 
Proposal Category 5406 Health care related service businesses (health care, public health care, health consultation, testing, sterilization, etc.)
5404 Various booking and arrangement businesses
0403 Pharmaceutical materials, pharmaceutical preparation(including biochemicals)
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.

Detail Description

Comprehensive Consulting for Drug Development (PMDA, FDA, EMA)

<< DESCRIPTION >>
Our company offers comprehensive consulting services for the development of medicinal products to clients in the United States, Japan and Europe.

Our services include strategic development for biologics and drugs with expertise in clinical development, regulatory strategy, regulatory operations (submissions), pharmaceutical development, business development, auditing, and quality management, and medical writing.

We are committed to support clients in meeting their business objectives, project milestones and customizes our approach to the needs of the client company.

Project Examples:
- Manage Manufacturing site and prepare study drug for clinical trial
- Manage GLP Toxicology Studies
- File NIH RAC
- File IND
- US/EU Regulatory & Legal Representative
- Identify the regulatory requirement and create strategy
- Support product development and preclinical work
- FDA Interactions and Consultation, etc.

If you are interested in our services, please feel free to contact us.
Please visit our webiste as well.

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