On request Regivet can write the textual (and tabulated) parts of the DACS for the pharmaceutical, the safety and residues and the (pre) clinical documentation. It is our experience that the tabular formats of the safety and (pre)clinical documentation – at least for full applications – may be very time consuming. However, if wanted Regivet can also arrange that.

• 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