Regulatory Affairs

07

Support for your research projects throughout the drug life cycle:

Study start-up:
- Analysis of requirements and drafting of documents necessary for presentation to the Research Ethics Committee for medicinal products
- Protocol design
- Submission and presentation
- Contract management
- Response to ethics committee queries
Monitoring and analysis of study results:
- Design and implementation of electronic CRF
- Monitoring of patient recruitment and resolution of queries
- Drafting of interim reports, final report and clinical study report
Positioning of the drug:
- Value dossiers
- Critical analysis of therapeutic positioning report (TPR) and advice on the drafting of allegations