We can also support clients with full applications, either via DCP or CP. In such cases we generally first start with a patent search to make sure there are no conflicts. Then a project overview is made with cost estimates for the development of the product and the required studies with go/no go moments at relevant stages. We will also include a risk analysis and give honest commercial advice, even if this could mean the project will not be continued. The client is always in control and can stop the project at any stage.

Note that Regivet does not conduct safety and /or residues studies in-house. Such GLP  studies are subcontracted to experienced contract research organizations (CRO)s. Clients may also conduct studies at their own preferred CROs. In all cases Regivet can review the protocols and reports or act as co-writer or Sponsors monitor; see also monitoring and second opinion.

(Pre)Clinical (GCP) studies can be set up completely by Regivet, but also – at request – conducted in cooperation with other companies taking the lead. Regivet collaborates with experts in the field and universities in the Netherlands and the United Kingdom.

• Generic applications
• Updates of existing dossiers
• New full applications
• Detailed and Critical Summaries
• Acting as applicant or assistance before and during applications
• Monitoring and second opinion
• ASMF/CEP evaluation
• Laboratory services