When updating existing dossiers for injectables, we regularly encounter problems with the preservative system; preservatives that were considered acceptable 10-20 years ago are often no longer suitable, due to the stricter criteria one nowadays needs to adhere to. For other types of products there are usually less issues, although updating a very old dossier may sometimes still be time consuming and thus costly, if there is only very limited information. However, on request we can also do parts of the development, e.g. update of analytical methods or only (ongoing) stability studies.

• 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