Kinesys Consulting
Regulatory affairs consultancy providing regulatory strategy, regulatory & medical writing, and regulatory support for drug and medical device development in Europe and internationally. Services include regulatory submissions (e.g., CTA, MAA), early-access and expedited pathway support (PRIME/PIM/EAMS/Breakthrough), paediatric and orphan designation advice, medical device conformity and standards guidance, regulatory due diligence, and clinical trial regulatory support.
Industries
Nr. of Employees
small (1-50)
Kinesys Consulting
Glasgow, Glasgow City, United Kingdom, Europe
Services
Comprehensive regulatory support including preparation of regulatory submissions, scientific advice, orphan and paediatric applications, and expedited pathway applications.
Regulatory and development roadmapping, pathway selection, expedited pathway planning and regulatory due diligence.
Creation of scientific and regulatory documents for submissions and communications.
Regulatory approval support and standards compliance advice for medical devices in Europe.
Comprehensive regulatory support including preparation of regulatory submissions, scientific advice, orphan and paediatric applications, and expedited pathway applications.
Regulatory and development roadmapping, pathway selection, expedited pathway planning and regulatory due diligence.
Creation of scientific and regulatory documents for submissions and communications.
Regulatory approval support and standards compliance advice for medical devices in Europe.
Expertise Areas
- Regulatory affairs and submissions
- Regulatory strategy and development roadmaps
- Early-access and expedited pathways
- Medical and regulatory writing
Key Technologies
- Regulatory submission frameworks (CTA, MAA)
- Early-access designation frameworks (PRIME, PIM, EAMS)
- Health authority scientific advice processes
- Regulatory and medical writing methodologies
News & Updates
Delivered a presentation on biosimilars clinical and regulatory strategies covering East-to-West considerations.
Reported acquisition of the company by another regulatory-services organisation.
Secured a PIM designation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on behalf of a partner for an oncology product under early-access schemes.
Obtained the company's first PIM designation from the UK MHRA under the Early Access to Medicines Scheme (EAMS) for an oncology supportive care product.
Delivered a presentation on biosimilars clinical and regulatory strategies covering East-to-West considerations.
Reported acquisition of the company by another regulatory-services organisation.
Secured a PIM designation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on behalf of a partner for an oncology product under early-access schemes.
Obtained the company's first PIM designation from the UK MHRA under the Early Access to Medicines Scheme (EAMS) for an oncology supportive care product.