Services offered by Rxn Regulatory Affairs include:
- Strategic advice on marketing authorisation applications, regulatory procedures and associated time lines and costs, the need to obtain manufacturing/import and wholesale dealers licences for specific activities
- Due diligence review of marketing authorisation dossiers for in-licensing purposes
- Regulatory compliance assessments
- Acting as the local Dutch representative of your company, either during specific regulatory procedures or on a regular basis
- Preparation, submission and follow-up of marketing authorisation applications and variations
- Updating of old marketing authorisation dossiers
- Preparation and updating of SmPCs and patient leaflets
- Conversion of dossiers to CTD format, and preparation of NeeS and eCTD submissions
- Interim management - temporary replacement of Regulatory Affairs staff during holiday periods, maternity leave etc.
- Preparing Dutch translations of SmPC, patient leaflet and labelling texts
- Rxn Regulatory Affairs offers theoretical and practical in-company Regulatory Affairs training sessions tailored to the needs and the experience level of your staff.