Request: Design Consultancy developed software which can visualise data exported from an EU CE Marked medical product. This client was to be the holder of the software licence and the EU CE Mark. They reached out to GRS to provide expert advice and guidance to establish the classification of the software and to support them in achieving compliance.
Outcome: GRS provided a regulatory strategy, conducted a gap analysis of the data held in support of the device, compiled the Technical File and submitted the required application to the Regulatory Authorities. The device has been registered successfully and the Declaration of Conformity provided.
Request: MedTech company approached GRS to undertake a regulatory evaluation of their device which diagnoses bladder problems. This evaluation to include a regulatory strategy and chronological development plan to obtain registration in Europe and to identify the correct device classification for the US and Japan.
Outcome: GRS brought together expertise from within the GRS network to deliver the requested report. The Team consisted of Medical Device Regulatory and Quality Compliance professionals with ‘on the ground’ working knowledge of the requirements for Europe, America and Japan. A Clinical Trial specialist was also brought on board. GRS provided a regulatory roadmap with reference to the regulations, guidance and ‘good practice’; confirmation of the device’s classification in America and Japan; and a review of the clinical studies which would need to be conducted to support an EU registration. The report was delivered on time and on budget. Implementation phase is being progressed.
Request: a multinational medical device manufacturer needed specialists to assess a sample of their extensive product portfolio against the new EU Medical Device Regulation (MDR). GRS was asked to review development plans against MDR to ensure compliance; to identify opportunities for re-use/re-purposing of devices; to update a sample selection of Technical Files to the requirements of MDR; to generate templates and processes for updating the Technical Files and to provide training.
Outcome: GRS integrated seamlessly with in-house expertise and achieved all requested deliverables. This assessment phase was a success and as a result the multinational has progressed to ‘implementation phase’.
Request: Abcam (Cambridge, UK) wanted to make a range of hard-to-source, highly active compounds available to the scientific community based around narcotics, cannabinoids and toxins. To assess the feasibility of this new business, Abcam came to GRS for advice on the regulatory and legislative situation in target territories.
Outcome: Based on GRS’s advice, Abcam acquired Ascent Scientific and relaunched this as AbcamBiochemicals.
Request: GSK came to GRS for specialist manufacturing advice (GxP and CMC) to help them approach the Regulators (US/EU) re continuous manufacturing.
Outcome: successfully completed this project on advanced control strategies for continuous manufacturing. GSK are successfully operating a continuous manufacturing unit at Ware, UK.
Request: a non-European company with a capsule inhaler identified a technology to improve drug delivery and patient compliance. GRS was asked to formulate a regulatory strategy so that this novel technology could be used once the original capsule inhaler had obtained an EU licence.
Outcome: GRS successfully supported and guided the company through the Scientific Advice procedure with the European Medicines Agency (EMA). Of particular importance was the good working knowledge of the GRS specialists with respect to CMC and clinical approaches to developing a commercially viable capsule inhaler. With valuable feedback from the EMA, GRS delivered a regulatory strategy which enabled the company to achieve its two key objectives: (a) to obtain a marketing authorisation for originator product and (b) to licence the follow-on product via the line extension route.