Services
Scientific and regulatory consulting
To assist you in all phases of your projects, Qualissima offers:
Regulatory strategy consulting:
- Analysis of customers needs and expectations
- Proposition of an adapted and relevant solution which takes into account: The objectives of theindustry (marketing, new indication, better product positioning...), The study feasibility in terms of financial andhuman resources; The regulatory strategy with the aim of the exploitation of the results
- Expert consultancy (national and international network of experts)
- Synopsis: Synopsis development after consulting experts'network
- Sponsor assistance with competent authority
- Selection of the study scientific committee members (specialist of the studied pathology, statistical experts...)
- Discussion and validation of the research protocol and the CRF
Medical writing :
- Technical writing: ethic committee dossier, competent authority dossier...
- Scientific writing: scientific articles (literature search, drafting and managing the publication in international journals)
Market access
Setting-up of European projects
