Preparation (CTD) and Application of the Drug Registration Dossiers

Our company offers professional consultancy service within the period elapsed from the stage of preparation of the registration dossiers up to the stage of obtaining license (marketing authorization).

Our consulting services you can receive on this subject are:

  • Professional consultancy within a period elapsed from the preparation of registration application dossiers up to the stage of obtaining the license (marketing authorization) including preparing the registration application dossiers for Medicinal Products for Human Use in CTD format in accordance with legislation, submitting the applications, conducting follow-up and carrying out the negotiations for solving the technical problems,
  • Preparation of SPCs/PILs and controlling them with regard to regulatory compliance,
  • Preparation of the analysis dossiers to be submitted to Department of Analysis and Control Laboratory of Turkish Medicine and Medical Device Agency, follow-up in order to conclude the analysis fast .
  • After obtaining license (marketing authorization), all transactions processes such as obtaining Sales Permission and Import Permit and Drug Representative Sample Permission Procedures,
  • To control the drug registration application dossiers in line with legislation, to inform the relevant company about missing information and documents in order them to provide the necessary documents/data,
  • Preparing the GMP (Good Manufacturing Practices) inspection application dossiers for Drug Manufacturing Plants, conducting their follow-up.