Services provided include:
– Activities for medicines, medical devices, food supplements and cannabis-based products
– Marketing Authorisation Application (MAA) through DCP, MRP or National Procedure
– Lifecycle management such as variations, renewals, line extensions
– Translations of Product Information including Linguistic reviews and Quality (QA) checks
– Artwork review
– Review of promotional material
– Legislation scanning
– Regulatory Intelligence
– Dossier conversion to eCTD format
– Communication with Malta Medicines Authority
We have over 18 years of experience in performing these services. Contact us and we can discuss how we can support you.
Countries covered
Through close collaboration with our partners we can provide Regulatory Affairs services for the following markets:
