At Client-Pharma, our team’s expertise can provide support for dossier submission, regulatory approval and the successful release of marketed products around the world.
Our regulatory services can support the release of medicinal products imported from locations other than the EU, and also include:
- Preparation of regulatory dossiers for the UK, Europe
- Management of EU mutual recognition and decentralized licensing
- Preparation or reformatting of DMFs into CTD format
- License maintenance including variations, renewals and Change of Ownership applications
- Preparation of SmPCs, labelling and leaflets
- Applications for Certificates of Suitability
- Liaison with Regulatory Authorities.