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
Camberley, Surrey, United Kingdom, Europe
Services
Strategic regulatory advisory (Advisory panel)
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.
Development support (agency advice, PIP/PSP, orphan, CTA/IND)
End-to-end support for agency meetings, paediatric plans (PIP/PSP), orphan designation, CTA/IND document preparation and submission management across ICH regions.
Regulatory affairs support and lifecycle management
Ongoing management of products through regulatory pathways, marketing authorisation application support, and lifecycle management activities.
Medical devices regulatory services
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.
Medical writing and regulatory documentation
Authoring and review of submission documents, clinical evaluation reports, post-market clinical follow-up documents, briefing packages and other regulatory writing deliverables.
Operational improvement and digital transformation
Process optimisation for regulatory and quality departments, digitalisation of systems, training and mentoring to improve operational capability.
Strategic regulatory advisory (Advisory panel)
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.
Development support (agency advice, PIP/PSP, orphan, CTA/IND)
End-to-end support for agency meetings, paediatric plans (PIP/PSP), orphan designation, CTA/IND document preparation and submission management across ICH regions.
Regulatory affairs support and lifecycle management
Ongoing management of products through regulatory pathways, marketing authorisation application support, and lifecycle management activities.
Medical devices regulatory services
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.
Medical writing and regulatory documentation
Authoring and review of submission documents, clinical evaluation reports, post-market clinical follow-up documents, briefing packages and other regulatory writing deliverables.
Operational improvement and digital transformation
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