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“GXPi were instrumental in helping the site achieve a MHRA license for our GMP manufacturing operations” Chief Operating Officer Excelsyn

Quality and Compliance Consulting

Implementing GxP quality systems, driving lean compliance and providing pragmatic validation management that deliver long term business benefit.

  • Team of GxP Quality and Compliance subject matter experts each with a minimum of 20 years’ industry experience covering QA, QC, IT, production, laboratory operations, engineering and validation
  • Our team of consultants is experienced in introducing and successfully managing GxP compliance and quality systems to EU (EMA), US (FDA), UK (MHRA) regulations and international guidelines such as ISPE GAMP® and ICH
  • Implementation of agile Quality Management Systems (QMS) that are fit for purpose and tailored to meet our customers’ needs, recognising some of our customers work across multiple industry sector verticals
  • Quality and compliance audit, gap analysis, risk assessment and action plan project management
  • Pre-inspection preparation and post inspection support for regulatory authority and corporate audits
  • Flexible validation and quality management solutions covering GLP, GCP, GMP and GDP compliance

Case Studies

  • Case Study: GMP Compliance Remediation Plan and QP Services Download
  • Case Study: Computer Systems GxP Compliance and Validation Strategy Download

Presentation Papers

  • ICH Q6B -implications for developers of biopharmaceuticals Download
  • Validating an EDMS – the lean and simply compliant way Download
  • The Paperless QMS Download
To find out more or to discuss your requirements please contact us by calling +44 115 924 8475 or email: info.ls@formpipe.com.