Drug regulatory affairs

Cometh together with local partners advice and assist during the registration process of medicines, food supplements and medical device as well as during the performance of  MA renewals and variations

Client

Ministery of health       

    ▪︎ Inform on various national registration requirements
    ▪︎ Adapt documentation according local laws
    ▪︎ Have necessary parts of the dossier translated
    ▪︎ Prepare of SmPC, PIL and labeling for approval
    ▪︎ Discuss and prepare answers to deficiency letters
     ▪︎ Check the dossier with the registration authorities
    ▪︎ Submit documents, samples and other relevant data
    ▪︎ File answers of deficiency letters
    ▪︎ Discuss and support progress of the registration process

Key Success Factors

    ▪︎ Keep strictly confidential all information, including know-how, to   
      which we have access during registration process

    ▪︎ Keep close contact with client and ministry of health during whole 
       registration process