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Regulatory Affairs

 
regu Our Scientific & Regulatory Affairs Department is involved in regulatory discussions to assure that the goals of your study meets the requirements of corresponding authorities. As the conduct of clinical research is closely linked to authorities’ guidelines, the Scientific & Regulatory Affairs Department is present to assist you in the development of your projects as per the latest requirements.

 

In addition to protocol development, the Scientific & Regulatory Affairs Department will take charge of the Clinical Trial Applications (CTAs) in order to ensure adherence to legislative demands. In parallel, the same staffs are invited to attend Ethic Committee meetings in order to rapidly answer questions. This way, approval time of each project is reduced

 

The department provides custom clinical trial reports carefully prepared according to regional guidelines of the following organisations:

 

  • European Medicines Agency (EMA)
  • International Conference on Harmonization (ICH)
  • US Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER)/Office of Generic Drugs (OGD)
  • Health Products and Food Branch (HPFB)/Therapeutic Products Directorate (Health Canada)
  • Therapeutic Goods Administration (TGA)