Medicines
The-vyne health insights can support all types of medicines development programmes covering prescription only, non prescription medicines, biologics and complex treatments today. The-vyne health insights expertise covers wide range of clinical fields, featuring specialist and truly novel treatments globally.
Our Services:
Regulatory Strategy & Marketing Authorisation Support
Marketing Authorisation – Medicines
We provide end-to-end support for Marketing Authorisation Applications (MAA) in alignment with:
Medicines and Healthcare products Regulatory Agency (MHRA)
European Medicines Agency (EMA)
Our support includes:
Regulatory strategy and pathway selection
Dossier planning and eCTD structure
Module review and submission coordination
Responses to regulatory questions
Post-approval variations and lifecycle management
Medical Devices – UK & EU
We support manufacturers under:
EU Medical Device Regulation (EU MDR)
UK Medical Devices Regulations
Services include:
Device classification and regulatory strategy
CE and UKCA marking preparation
Technical documentation review
Clinical evaluation support
Notified Body readiness
Clinical Trial Applications (CTA)
We provide full regulatory support for clinical trial submissions in the UK and EU.
Services include:
CTA preparation and submission
Protocol and documentation review
Ethics committee coordination
Regulatory responses and amendments
- New Trial Submissions: Supporting preparation of initial CTR-compliant trial applications.
- Maintenance of Ongoing Trials: Handling substantial and non-substantial modifications, DSUR submissions, and milestone notifications.
- Document redaction: Ensuring adherence to transparency obligations while safeguarding personal and commercially confidential information.