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.
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
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
Management, Supervision and Training
Design and lead projects
Supervise and train staff
What We Do
We are a London-based regulatory affairs consultancy providing services to the e-cigarette, cosmetic, biocide and pharmaceutical industry. We help e-cigarette companies comply with the Tobacco Products Directive and pharmaceutical companies obtain and maintain medical product licences. We also offer UKAS accredited biocide and analytical testing services.