Endorse Company
Expert Regulatory, Quality and Clinical Consultants Advance Regulatory Consulting Limited is a specialised consulting firm dedicated to the medical device and diagnostics industry. Located in Northern Ireland and serving clients across the EMEA and Asia-Pac regions, our consultants have an enviable track record of success with both global leaders in the medtech industry as well as SME and start-up organisations. We additionally provide EC Authorised Representative services to device manufacturers looking to place devices on the Community market. REGULATORY: Utilizing a gold-standard yet pragmatic approach, we will integrate with your teams to develop a regulatory strategy that ensures commercial objectives are met, timelines are achieved and your development and submission activities are optimised. QUALITY: Our QMS department provide outsourced 3rd party audit services to EU notified bodies, QMS development for device manufacturers and service providers, Internal audit support and 2nd and 3rd party external audit preparation. CLINICAL: Our clinical operations business can help you understand the requirements for clinical data in global markets, how to leverage scientific publications, bench test and in vivo model data, develop a clinical strategy for your development project and where required, organize and plan global clinical trials in accordance with GCP and local ethical requirements. We provide outsourced clinical site monitoring and clinical QA services for global device clinical trials. TRAINING & DEVELOPMENT: Our consultants can work with your organisation to establish training and development programmes that can be delivered and rolled out across your teams. Delivering training that has been tailored to your specific needs and challenges maximising the understanding and the effectiveness of the programme. We can also provide 1-2-1 coaching and mentoring services for senior regulatory, clinical and quality personnel. Downloads: ARC Company Brochure Advance Regulatory Consulting Company Flyer V2 (by email).pdf Service Synopsis Synopsis.pdf