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Regulatory Services
We have a team with extensive knowledge and experience in all aspects of EU Regulatory requirements.
These Regulatory Affairs experts can provide the following services:
Regulatory project management
- Project planning and progress reports
- Outsourcing management IE: translation services, packaging artwork design and PIL user testing
- Advice on submissions strategies
- EU Decentralised (DCP), Mutual Recognition (MRP) and National Procedures for obtaining Marketing Authorisations. This includes the generation of product information texts and SmPC comparisons
- Thorough review and compilation of dossiers (Modules 1 – 5) and submission in compliant eCTD format
- Preparation of Quality Overall Summaries, Clinical and Nonclinical overviews and summaries
- Advice on the quality of existing documentation to ascertain compliance with current regulatory requirements
- Re-formatting of dossiers from the old style NtA format to CTD
- Liaison with health authorities throughout the procedure. This includes requesting submission slots for DCPs
- Co-ordination and compilation of formal responses to requests for further information on behalf of proposed marketing authorisation holder (MAH)
- Follow-up on the national phase after finalisation of European procedures, involving the submission of high quality national translations of finalised and harmonised SmPCs, Patient Information Leaflets and Labelling to the Reference Member State (RMS) and Concerned Member States (CMSs)
- Acting as authorised contacts with the health authorities during and after the procedure in all EU member states
- Variations
- Renewals
- Labelling updates
- Licence transfers
- Change of ownership applications
- Regulatory due diligence