Regulatory Affairs

Our Scientific & Regulatory Affairs Department is involved in regulatory discussions to assure that the goal of your study meets the requirements of corresponding authorities.

Regulatory Affairs

Our Scientific & Regulatory Affairs Department is involved in regulatory discussions to assure that the goal 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 staff is invited to attend Ethic Committee meetings in order to rapidly answer questions. This reduces the approval time of each project.

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

  • 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)
  • European Medicines Agency (EMA)
  • International Conference on Harmonisation (ICH)
  • Therapeutic Goods Administration (TGA)

Projects conducted over the years have been reviewed and approved by major authorities, and have been successfully audited by the following agencies:

  • US Food and Drug Administration (FDA) (USA)
  • Therapeutic Products Directorate (Health Canada)
  • Agência Nacional de Vigilância Sanitária (ANVISA) (Brazil)
  • Agence nationale de sécurité du médicament et des produits de santé (ANSM) (France)
  • Medicines and Healthcare products Regulatory Agency (MHRA) (United Kingdom)
  • Austrian Agency for Health and Food Safety (AGES) (Austria)
  • Department of Medical Sciences, Ministry of Public Health (Thailand)
  • Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (Spain)