Regulatory and Medical Affairs, MultiHealthGroup

Regulatory and medical affairs

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Maximize the value of your clinical trials within a well-managed regulatory framework

Our Regulatory and Medical Affairs department supports your clinical projects at every stage to ensure compliance, scientific quality, and efficacy. From the initial submission to regulatory authorities to the dissemination of results, our experts provide rigorous management of regulatory requirements with strategic medical support. We bridge the gap between science, regulation, and operations to facilitate the availability of healthcare products. Through active regulatory monitoring, our teams ensure the smooth, secure, and transparent management of your projects, while strengthening the scientific and regulatory credibility of your development efforts.

Regulatory Management of Clinical Trials

Biostatistics A robust scientific foundation
Strategic Regulatory Advisory: Assistance in defining a regulatory strategy based on the type of study, the product, and the geographic scope.
Submissions and Approvals: Preparing and tracking submissions to the relevant authorities and ethics committees until trial approvals are obtained.
Regulatory monitoring: actively tracking legislative developments and continuously adapting processes to maintain compliance.

Medical and scientific support

Biostatistics Rigorous analysis and interpretation
Thorough review of documents: scientific validation to ensure the quality of the protocol and the safety of participants.
Training and support for investigators: assisting centers to ensure compliance with the protocol.
Medical oversight of the study: ongoing monitoring of trials, management of adverse events, and consultation with sponsors.

A Comprehensive Assessment

Biostatistics Interpreting the results
Report Submission: Drafting and filing of safety reports, CSR, CER, and other regulatory documents.
Scientific publication: writing articles, abstracts, or posters to highlight the impact of the data.
Product lifecycle: post-marketing support (pharmacovigilance, observational studies, responses to regulatory authorities).

Ensuring the security of your research and maximizing the value of your data for the greatest possible scientific impact

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Compliance & Security

Our services comply with the most stringent regulatory frameworks governing health data.

Your clinical data is hosted exclusively by providers certified as Health Data Hosts, in accordance with the requirements of the ANS and the Public Health Code.

Your clinical data is hosted exclusively by providers certified as Health Data Hosts, in accordance with the requirements of the ANS and the Public Health Code.

Our teams are at your service

contact@multihealthgroup.com

01 80 13 14 70

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