Product description

Health Clinical Research is regulated differently across countries, major regulatory bodies such as the EU Commission and FDA continuously update and change legislation associated with conducting clinical trials. However, ICH GCP Standards are unique in bringing together the regulatory authorities as well as the industry requirements. Their mission is to ensure safety, effectiveness and high-quality treatments within the clinical studies.

Medical Association Guidelines and Ethical principles such as The Helsinki Declaration which is prepared in line with WHO policies and guidelines (international and /or national) play a key role in our regulatory process. 

At Atlantia, we take into consideration the regulatory environment of the sponsor company to provide a highly compliant clinical research from the study design through to reporting. Our regulatory services include ethical submissions and approvals as well as the main health agencies health claims submissions 

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