Marketing Authorisation Support

Marketing Authorisation is a legal requirement before a product can be placed on the market. Dependent on the product and your ambitions – Peritus can help you determine the most appropriate regulatory route to filing and the associated submission procedure.

Peritus Regulatory support:

• Reviews of data and assessment of adequacy for intended use. This includes non-clinical, clinical and quality of data sets.
• Advise on the suitable regulatory filing approach ensuring compliance to the most current regulations.
• Experienced in the preparation, submission and review of regulatory dossiers e.g. clinical trial applications (CTAs), MAAs and variations, responses to FDA/EMEA questions.
• Regulatory project management – for companies who require our expertise to co-ordinate the process – we can manage NDAs/BLAs/MAAs/Orphan drug submissions and briefing book preparation.