Licensing & Product Registration
We are able to offer specialised services for a multitude of pharmaceutical regulatory processes.
Client-Pharma, through their outstanding reputation as a partner of choice for pharmaceutical companies around the globe, is able to offer specialised services for a multitude of pharmaceutical regulatory processes.
We can provide support across the lifecycle, including product registration and licensing processes. With our extensive experience in regulatory services for the pharmaceutical industry, we can help you achieve your objectives.
Here, we can provide support for product registration regarding the following:
- Auditing the facility to comply with EU regulations
- Preparation of regulatory dossiers for the UK, Europe
- Management of EU mutual recognition and decentralized licensing
- Preparation or reformatting of DMFs into CTD format
- Preparation of SmPCs, labelling and leaflets
- Applications for Certificates of Suitability
We fully recognise the critical importance of timelines and target deadlines to ensure your CT project ultimately delivers commercial rewards.