We have helped clients design, develop and commercialize many novel and 'world-firsts' in
the European (CE notified body) and USA FDA markets. US including FDA PMA, CLIA and 510k approval routes and non-therapeutic combination products.
We have designed, setup and validated supply chains to meet the most rigorous and complex regulatory requirements.
Our expert advisors allow clients immediate access to the required regulatory advise including ISO 13485:2016, ISO 14971:2019, IVDR and 21 CFR part 820. We conduct thorough risk and gap assessments and provide detailed step-by-step plans to ensure compliance is build in to the supply chain at the early stage.
Our clients leverage our extensive network to select the right design partners and develop the optimal regulatory pathway and route to market including pre-compliance and compliance test and certification.
Design for test, design for compliance and design for manufacture methodologies (DFx).
We ensure clients select the best contract manufacturing partners to meet their specific requirements. We can support the technology transfer, validation and production scale. GMP expertise in many life science spaces.
We have deep and recent sourcing expertise in the EU, USA and Asia for CMO, including lyophilisation and fill finish, and CDMO partners.
We have designed, implemented and validated many supply chains including chain of custody of high value and risk drug products, devices and IVDs. Cold chain design, process development and validation.