Drugs Other

The new regulations (after 25th Dec, 2014) can be summarized as follows.

Application Procedures (Agency service is available.)

  1. Application for registering drug substances

  2. Application for issuing export certificate

  3. Application for issuing Yakkan certificate

  4. Application for approval and verification

Manual Documentation (Simplified procedure service is available.)

  1. Documentation of GMP manual for drug

  2. Documentation of GQP manual for drug

  3. Documentation of GVP manual for drug

Consultation Services

  1. Consultation on new drug development

  2. Consultation on documentation of HP in compliance with pharmaceutical law
           (which has taken effect since 25th Dec, 2014)

  3. Consultation on documentation of product standards or quality standards

  4. Support for CTD documentation


  1. Investigation of drug ingredients (determine whether appropriate ingredients are used)

  2. Investigation of GMP of foreign manufacturing (field investigation)

  3. Investigation of analysis on drug ingredients

Feel free to contact us!
(9 AM-6 PM, Mon to Fri)