Regulatory Support

The manufacture and packing of medical products is heavily regulated.

We are Proud Of Our Record

FMP is fully compliant with all regulation outlined by the MHRA (Medicines and Healthcare Products Regulatory Agency), the UK’s regulatory body for medical products. Furthermore, all of FMP’s systems and procedures are audited by the notified body SGS Yarsley. FMP is very proud of its record with regard to outgoing product quality. A significant element of our operations budget is given to the maintenance of our robust quality management systems.

Customer Audits

The audit records for current and historic performance are available for inspection by our customers at all times and the business is pro-active in encouraging regular customer audits to its site in Lancaster.

Technical Team

The MHRA frequently updates and alters legislation and our Technical Team is available at all times to advise customers with regard to current legislation for both chemical, componentry and pack mandatory graphics relating to the healthcare industry and cosmetics.

Dedicated Team

Currently, FMP employ eleven people dedicated to quality assurance & control including four qualified chemists.

Regulatory Support Services from FMP

  • Technical file construction
  • Assistance with Drug Tariff applications
  • Full data & validation support
  • Full regulatory support from development to finished product
  • Full supply chain traceability
  • Over 25 years of medical device & contract manufacture experience

For more information, please see our quality & environmental policy or view our licences & certifications.

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Artwork Design Service

We can assist with compulsory regulated labelling that must appear on product packaging. View our artwork design services for further details.

View Artwork Design
Need More Information?

Call Us On +44(0)1524 68737 or Send us a Message