Services offered by Rxn Regulatory Affairs include:

Advice

• 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

Practical assistance

• 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

Training

• Rxn Regulatory Affairs offers theoretical and practical in-company Regulatory Affairs training sessions tailored to the needs and the experience level of your staff.