Services to the pharmaceutical industry:

Registration of a Medicinal Product

  • 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

Management, Supervision and Training

  • Design and lead projects
  • Supervise and train staff