Preparation, submission and co-ordination of MRP applications as RMS and CMS
Preparation and submission of abridged Marketing Authorisation applications
Preparation of application forms, SmPC, Patient Information Leaflets and packaging ensuring that technical, regulatory and commercial requirements are met
Monitoring the progress of MA applications, minimising delays and anticipating potential issues.
Life-Cycle Maintenance
Preparation, submission and co-ordination of national and MRP variation applications.
Licence Transfer applications in the EU
Preparation, submission and co-ordination of product licence renewals and other amendments to product licences
Other Services
eCTD Publishing: Fast, efficient turnover
Dossier conversions from US to EU format
Regulatory due diligence on company for acquisition
Clinical Trial Support
Arrange clinical trial to support MA applications
Monitor and report on progress of clinical trial
Highlight potential issues and minimise delays
Co-ordinate trial with related regulatory activities