Services

Scientific and regulatory consulting

To assist you in all phases of your projects, Qualissima offers:

Regulatory strategy consulting:

Analysis of needs and expectations for proposing adapted and realistic solutions which takes into account: The objectives of the customer (marketing, new indication, better product positioning...), the study feasibility in terms of financial and human resources, the regulatory strategy with the aim of the exploitation of results
Expert consultancy (national and international networks)
Sponsor assistance with competent authority
Proposal of scientific study committee members (specialist in the studied pathology, statistical experts...)

Scientific and Medical writing :

Synopsis and clinical protocols
Clinical study reports
Investigator's Brochure (IB)
Ethics committee and regulatory authority dossiers
Scientific articles (literature search, drafting and managing the publication in international journals)
Communication: newsletters, abstracts, posters...
International databases (clinicaltrial.gov...)

Setting-up of collaborative projects (French (ANR), European (H2020), Indo-European)