There is no special regulation for Pharmaceutical Excipient Registration in China, there are lots of 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 China. Therefore, an experienced consulting agency is able to assist you to prepare the Application Dossier according to the requirements, and handle the registration procedure smoothly.
Import pharmaceutical excipient is similar to import drug on registration in China. We have assisted lots of foreign manufacturer obtained IDL(Import Drug Licence) and 1 foreign manufacturer obtained IPEL 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 China without policy obstacles or illegal situations.
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 China or not.
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. |
