We have a proven track-record when it comes to quality. We work continuously to ensure we create high quality, safe products through lean and efficient processes.
We have a host of knowledge and experience in ensuring quality in development and dealing with the regulatory requirements of the pharmaceutical industry. In accordance with our customer requirements, we can complete, or assist with, regulatory submissions including collation of technical files, undertaking risk analysis and design validation.
To ensure quality is built into our operational platforms we operate a mature Quality Management System (QMS), conforming to ISO 13485. Alongside this, we use a number of techniques to make sure every product meets strict quality standards in a robust and repeatable manner over millions of devices per annum.
Quality & Regulatory Core Competences Systems
We understand that adherence to quality and regulatory requirements is key to the successful supply of products into the pharmaceutical, medical and diagnostics industries.
Working directly with regulators and pharmaceutical and medical device customers over many years has given us a deep knowledge of what is required. We understand the interface between drug and device, and have a wealth of experience in working with customers to navigate the regulatory and quality pathway from early stage through to full commercialisation.
Central to our capability is our experience in the drug and device interface. This experience is characterised by:
- Compliance with the applicable CFRs and cGMP requirements
- ISO13485 accreditation
- Holding pharmaceutical manufacturing licences issued by MHRA
- GMP accredited laboratory
- Analytical laboratory with broad portfolio of capability (e.g. GC-MS, NGI, IR, Particle Sizing etc)
- Provision of data into regulatory documents, writing relevant CTD sections
- Filing and maintenance of a portfolio of Drug Master Files
- An appropriate manufacturing infrastructure including Part 11 compliant SAP ERP system, full product and part status/traceability control, cleanrooms and metrology
- Validation and verification knowhow
- In vitro diagnostics manufacture and reagent handling.
The supply of complex medical products in a highly regulated sector requires extensive collaboration with our customers. We believe we can supply the right quality, regulatory skills and experience to partner with any customer successfully.
View our Latest ISO 14001 Certificate
View our Latest TUV ISO 13485 Certificate