Phone: +44 141 899 0081

Our Regulatory Affairs Services

Scientific Advice

Kinesys can help you get advice from relevant Regulatory Agencies and HTA Bodies.

Paediatric Investigation Plans

Kinesys can help you navigate the PIP process and contribute towards a successful outcome.

EMA / FDA Orphan Drug Designation

Kinesys helps put you a smooth path to the orphan designation and beyond.

PRIME & PIM Schemes

Kinesys can help you understand the expectations required for a successful designation.

Clinical Trial Applications

Kinesys can help you prepare review and submit your CTA to Competent Authorities and Ethic Committees.

Marketing Authorisation Application & Oral Explanation

Kinesys can help you through all stages of your MAA.