Our Regulatory Affairs Services
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.