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.