Often it is the smallest of details that gets in the way of quick submission, which in turn delays your product’s market entry. Do you need a slot? Are you acquainted with your contact persons at the national authorities? Do you know which is the right RMS for your product? Regulatory Affairs Consultancy will find the right pathway for you.
- Preparation and execution of submissions to European regulatory authorities in electronic and/or paper form.
- Support for authorisation procedures, including communication with regulatory authorities
- Follow up for deadlines and timelines
- Support in the preparation of product information (e.g. readability test, translations)
- Preparation and follow-up for procedures
- Organisation of meetings