Regulatory Affairs

As regulations and their interpretation are changing so quickly we prefer to work with experts who are continually involved on the latest applications in this field. Therefore, we have formed a tried and tested collaboration with a long established Regulatory Affairs consultancy and find that provision of a mixture of specialist advice and ‘hands on’ compilation of regulatory dossiers works well for our Sponsors – particularly virtual Biotechs who may require more supportive guidance through the regulatory process.

The clinical operations team within PRN are able to provide support with the completion of CTAs.

Services offered include:

• Consultancy and Strategic Development for Clinical Research
• Due Diligence for New Product Licensing
• Registration Strategy and Support
• Clinical Research Product Development