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Regulatory Affairs

01Mission & Duties
  • The mission of Kolmar’s Regulatory Affairs specialist and professionals is to prepare and file demands for regulatory approval of the products of ourselves as well as our customer’s company.
    We prioritize to make sure the registration dossier strictly follows KFDA’s requirement and regulations relevant to pharmaceutical products and to get the MA within KFDA’s designed timeline of regulatory process with the low rate of turnaround of submitted dossier.
  • In addition, with strong administrative tasks to Korean regulatory authority (KFDA), the authorization period from submission to approval is to make shorter than expected one.
    Based on above, our experienced and skilled regulatory people do their best to provide a very strategic role and have more delineated regulatory services to our customer who wants to get penetrated into Korean pharmaceutical market.
02Principal Service to our customer
Prepare, coordinate and supervise regulatory submissions
  • Review product conformance and assure compliance
  • Implement different strategies in order to meet evolving regulatory initiatives
  • Register products according to guidelines and regulations of KFDA
  • Keep current with regulations
  • Participate in conferences and interdepartmental meetings
  • Discuss with KFDA authority about issue involved in all stages of the MA submission process
  • Search of IP ( Especially, patent status of pharmaceutical products, trademark )
  • Market search in Korean pharmaceutical industry and consulting to customers
  • Product Development proposal
  • Arrange BE and clinical study in Korea
03Resources
Our 15 Regulatory Affairs Specialist have stayed with Korean pharmaceutical industry for an average of 10 to 15 years. As networking is very much well established, it’s more convenient to access KFDA’s people and current literature.
Number of authorized MA can prove their ability.

Total number of MA authorized by KFDA :- ETC : 165- OTC : 186- Others : 163
If you would like to apply MA of your products to KFDA, please consult with Kolmar’s regulatory specialist. It can make you go on the right way without wasting time.
04Process
KFDA’s official MA process and Timeline from submission to approval
If you would like to know about KFDA’s official MA process and timeline in detail, please contact to RA division. We will help you to make it access efficiently into Korean market.