Though the requirements for review of drug registration in China are more and more in accordance with ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), there are still lots of differences and special local requirements. You might waste much more time on supplement or recomposition of Application Dossier if you do not understand the special requirements of drug registration in
We have assisted lots of foreign manufacturer obtained IDL (Import Drug Licence) successfully, we know how to guide the manufacturer on preparation of Application Dossier, and avoidance of failures and defects in registration procedure.
Our consulting services including:
1. Evaluating whether your products can be registered in
2. Assessing how many fees and how long the procedure takes.
3. Guiding how to prepare the data and information on Application Dossier. We will send a Reference Brochure to manufacturer/company, there are detailed explanations and collected pitfalls on each item of Application Documents in this Reference Brochure.
4. Reviewing the data and information provided by manufacturer/company, then estimating whether they meet the requirements of
5. Translating, compiling the Application Dossier in Chinese.
6. Tracking and handling the registration procedure, then ensuring manufacturer/company could obtain IDL or CTP in time.
7. Organizing and monitoring the clinical trials.
8. Technical support.