• Mr.lidi
    Tel: 86-025-84989826/ 52880806

  • Ms.mandy
    sales
    Tel: 02584989826

  • Fax:86-025-52880803
  • Province/state:Jiangsu
  • City:Nanjing
  • Street:No.18 Zhilan Road ,Jiangning District , Nanjing
  • MaxCard:
2015/10/29 14:33:15

Generic Drug reasearch

A generic drug (generic drugs, short: generics) is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. It has also been defined as a term referring to any drug marketed under its chemical name without advertising.

  Service process:

  1、Our company will screen proper projects based on a customer's existing production lines, the existing variety of categories, existing distribution channels and future development needs.

   2、Our professional staffs will research the major categories according to customer demand, the initial screening some of the projects for selected customers. If customers agree with our results, the further project will be discussed, the feasibility of regulations have been listed on the situation, the situation has been declared, R & D cycle, production is expected to receive approval document time (calculated according to time of drug registration regulations), the customer is expected in areas such as investment costs need to be discussed carefully, a complete research report will be given to the customer.

   3、According to customer requirements, with the national drug registration rules-oriented, conscientious and responsible to carry out pharmaceutical research experiments, data reporting the preparation of the test with a small test sample preparation, guidance related to process validation production companies, pilot production, dynamic verification, the stability Research, and report to the Food and Drug Administration, with the associated session for review and site inspections to obtain review of the department's approval.

  4、Concern the progress of the project with the manufacturers and get approve of producing, and finally complete projects cooperation.

 

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