With over 30 years of international experience in Regulatory & Medical Writing covering most therapeutic areas, Kinesys is perfectly placed to provide expert support for all types of writing projects, even the most challenging.
We are a very experienced, flexible team committed to producing the highest quality documentation, while making the process as simple and straightforward as possible for our clients. Our very high level of repeat business speaks for itself.
- We are an expert team of medical, regulatory and scientific writers comprising industry-experienced, PhD-level scientists and qualified physicians, all with excellent communication skills.
- Our writers’ scientific, clinical and regulatory experience, as well as their therapeutic area knowledge, ensures accurate, high quality, submission-ready documents.
- We are recognised by our peers and our clients for our high standards of accuracy, clarity and consistency of messaging within and across all documents.
- All documents are prepared according to either an internal or client style guide, and follow a streamlined authoring and review process; all documents are subject to quality assurance review prior to release.
- We pride ourselves on our excellent levels of responsiveness to clients.
- For every project, we offer several meetings / telecons, moderated by our team leaders, to ensure that we are delivering exactly what our clients need and expect at all times.
We cover a wide range of therapeutic conditions with exceptional knowledge of the following areas:
- Oncology Haematology
- Neurology & Psychiatry
- Cardiovascular
- Metabolic Diseases
- Immunology
- Ophthalmology
We provide our expertise to all types of companies, from startup biotechs to major pharma firms located in Europe, UK, USA and other global regions.
Please contact us to discuss how we can help you to Get it Write!
Regulatory Writing
- Briefing Documents for Scientific Advice (EU) or US FDA Meetings
- Orphan Drug Designation and Maintenance supporting documentation (EU, UK and US)
- Paediatric Investigation Plan (PIP / iPSP) supporting documentation (EU, UK and US)
- Early Access Pathway applications (PRIME (EU), ILAP/EAMS (UK), Fast Track (US), Breakthrough Therapy (US), QIDP (US), Regenerative Medicines Advanced Therapy RMAT (US)
- IMPD / CTA (EU, UK) and IND (US)
- Briefing Document for Innovation Task Force (EU)
- Regulatory responses to agency questions
Marketing Authorisation Applications: Clinical and Nonclinical Documents
- Module 2.4: Nonclinical Overview (EU / US)
- Module 2.5: Clinical Overview (EU / US)
- Module 2.6: Nonclinical Summary plus tabulations (EU / US)
- Module 2.7: Clinical Summary plus tabulations (EU / US)
- Integrated Summary of Efficacy (US)
- Integrated Summary of Safety (US)
- Risk Management Plan (EU)
- Clinical Evaluation Reports (for EU / UK Medical Devices)
Product Information
- Product Information (USPI; EU SmPC, PIL; labelling)
- Core Data Sheet (Global)
- Patient Information Leaflet (PIL) for EU / UK
- Package labelling
Medical & Clinical Writing
- Protocols
- Protocol synopses
- Protocol amendments
- Investigators’ Brochures (IBs)
- Lay Language Summaries for Clinical Trial Results
- Clinical Study Reports (CSRs)
- Patient narratives
- Development Safety Update Reports (DSUR)
- Periodic Safety Update Reports (PSUR)
Scientific Communications
- Manuscripts (including strategy discussions, literature review, summary tables and referencing)
- Abstracts
- Posters
- Literature searches and summaries
- Review articles