RApport Global Strategic Services
Rapport Global Strategic Services Ltd is a global regulatory consultancy supporting the pharmaceutical, biotechnological, and medical device industries. Founded in 2003, it offers strategic regulatory support, development support, regulatory affairs support, and operational improvements. The company is committed to strengthening its clients' future through defining strategies based on extensive knowledge of global regulatory pathways and providing practical support. It has a team of highly experienced regulatory experts and a wide network of specialists, supporting clients in managing development programs and navigating complex regulatory processes worldwide. The company emphasizes strategic input, clear vision, and regulatory expertise to support all aspects of development and ensure success.
Industries
Nr. of Employees
small (1-50)
RApport Global Strategic Services
Arena Business Centre, Riverside Way, Watchmoor Park, Camberley, GU15 3YL
Services
Provision of a standing advisory panel to review development programmes, identify risks and opportunities, facilitate KOL engagement and advise on global regulatory pathways and accelerated routes.
End-to-end support for agency meetings, paediatric plans (PIP/PSP), orphan designation, CTA/IND document preparation and submission management across ICH regions.
Ongoing management of products through regulatory pathways, marketing authorisation application support, and lifecycle management activities.
Support for CE marking, technical documentation, conformity assessment, notified body engagement, clinical evaluation (CER/PMCF), QMS (ISO 13485) and vigilance reporting; includes PRRC support and due diligence.
Authoring and review of submission documents, clinical evaluation reports, post-market clinical follow-up documents, briefing packages and other regulatory writing deliverables.
Process optimisation for regulatory and quality departments, digitalisation of systems, training and mentoring to improve operational capability.
Provision of a standing advisory panel to review development programmes, identify risks and opportunities, facilitate KOL engagement and advise on global regulatory pathways and accelerated routes.
End-to-end support for agency meetings, paediatric plans (PIP/PSP), orphan designation, CTA/IND document preparation and submission management across ICH regions.
Ongoing management of products through regulatory pathways, marketing authorisation application support, and lifecycle management activities.
Support for CE marking, technical documentation, conformity assessment, notified body engagement, clinical evaluation (CER/PMCF), QMS (ISO 13485) and vigilance reporting; includes PRRC support and due diligence.
Authoring and review of submission documents, clinical evaluation reports, post-market clinical follow-up documents, briefing packages and other regulatory writing deliverables.
Process optimisation for regulatory and quality departments, digitalisation of systems, training and mentoring to improve operational capability.
Expertise Areas
- Regulatory strategy and global submissions
- Clinical trial applications and clinical development
- Medical devices regulatory compliance and CE marking
- Medical writing and regulatory labelling
Key Technologies
- Data science for regulatory insight
- Intelligent automation
- AI-driven regulatory methodologies
- Digitalisation of regulatory and quality systems
News & Updates
Announcement of a new team member joining ELIQUENT Life Sciences UK in October.
Announcement of new hires at ELIQUENT Life Sciences UK following acquisition of Rapport.
The UK team partnered with Surrey County Council’s Surrey Heathland Partnership for a volunteer environmental conservation day.
A blog post by Sarah, a Senior Regulatory Affairs Officer, sharing her recent travels in Asia.
A team participation in a presentation skills training session led by Mark from Glass Box Thinking Ltd.
Announcement of a new team member joining ELIQUENT Life Sciences UK in October.
Announcement of new hires at ELIQUENT Life Sciences UK following acquisition of Rapport.
The UK team partnered with Surrey County Council’s Surrey Heathland Partnership for a volunteer environmental conservation day.
A blog post by Sarah, a Senior Regulatory Affairs Officer, sharing her recent travels in Asia.
A team participation in a presentation skills training session led by Mark from Glass Box Thinking Ltd.