Our Regulatory Affairs Services
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Scientific Advice
Kinesys can help you get advice from relevant Regulatory Agencies and HTA Bodies.
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Paediatric Investigation Plans
Kinesys can help you navigate the PIP process and contribute towards a successful outcome.
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EMA / FDA Orphan Drug Designation
Kinesys helps put you a smooth path to the orphan designation and beyond.
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PRIME & PIM Schemes
Kinesys can help you understand the expectations required for a successful designation.
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Clinical Trial Applications
Kinesys can help you prepare review and submit your CTA to Competent Authorities and Ethic Committees.
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Marketing Authorisation Application & Oral Explanation
Kinesys can help you through all stages of your MAA.