Apotech Consulting is fully committed to supporting the provision of outsourced Quality and Regulatory services, across the full spectrum of the product life cycle, within the MedTech, Diagnostic and Biotech space. As a trusted global partner and proven life-science specialist, Apotech prides itself on delivering flexible, bespoke solutions tailored to meet the varying needs of its clients. Some of our managed services include: - UKCA & CE Marking - EU MDR & IVDR transition - UK Responsible Person (UKRP) - FDA Regulatory submissions; 510(k), De Novo, PMA - CER/ PER Authoring - Regulatory Strategy - ISO 13485/ ISO 9001 QMS development and maintenance - Acting as QP or RP for release of medicinal products - GCP, GMP, GDP, GVP Audits View the full extent of our services on our website.