Regulatory Affairs
Support with Regulatory Affairs
The compliance of clinical studies with legislation and regulations is essential to ensure the viability, integrity, and credibility of clinical studies.
The regulatory affairs support service ensures that all documents are prepared considering the regulatory component of the study, as well as whether responses to regulatory authorities comply with national and international legislation, good clinical practices, and the specific requirements of the therapeutic area. This service is performed by a specialised technical team that identifies the legislation and regulations applicable to the study, and assists in preparing responses to requests from Regulatory Authorities, ensuring their alignment with current regulations.
Through the provision of a regulatory affairs support service, we aim to simplify interactions with regulatory authorities and ensure that the clinical study complies with current legislation, strengthening its quality and credibility.
If you require support with regulatory affairs, simply click on "request service".
What will you have access to when requesting this service?
List of laws and regulations: Identification of relevant laws and regulations for the clinical study;
Response to requests: Support in drafting responses to clarification requests from regulatory authorities;
Others: To be defined on a case-by-case basis.
Necessary Documentation
- Clinical study protocol or synopsis
- Document with questions raised by regulatory authorities
