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 Biotech, MedTech and IVD industries. 

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:

- Global GxP Audits {GCP, GLP, GMP, GDP, GVP} 
- ISO 13485/ ISO 9001 QMS development and maintenance 

- UKCA & CE Marking 
- EU MDR & IVDR transition
- UK Responsible Person (UKRP)
- EU Authorised EU-AR
- FDA Regulatory submissions; 510(k), De Novo, PMA
- CER/ PER Authoring 
- USA & EU Regulatory Strategy 

View the full extent of our services on our website.

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