Quality Compliance Consulting Services

Regulatory Affairs

Proclinical’s Compliance Services is dedicated to delivering turnkey solutions to support life science companies as they struggle under the pressures of increased scrutiny by health authorities. Our expert recruiters, specialist project teams and effective project management strategies can operate either locally or globally to suit any scope of work. Each project will be strategically planned to not only fulfil needs but to optimise company productivity and success. Proclinical can leverage its regulatory and compliance expertise with its strong relationships with regulatory bodies to deliver seamless, high-quality and cost-effective solutions to companies.

Compliance services we provide:

  • Strategic advice for structuring quality assurance and compliance programmes
  • Site facility compliance and GMP audits/assessments
  • Quality system, pre-approval, GCP audits and mock FDA/EMA inspections
  • Inspection readiness assessments
  • Data integrity assessments
  • Training of local staff to raise standards and ensure culture changes
  • Assistance in preparing correspondence with FDA (inspections and warning letters)
  • Preparation and execution of CAPAs
  • Investigation and closing of deviations
  • Due diligence assessments
  • Application of GMP to emerging technologies
  • Management and execution of product recalls

Benefits include:

  • Highly skilled and experienced turn-key specialist teams
  • Expert, multi-lingual resource team
  • A global service; ability to work from site to site
  • Dedicated point of contact on site and structured governance programme
  • Efficient and flexible alternative to permanent hiring, with added benefit of focusing on
  • in-house staff on core growth activities
  • Reduced time and costs compared to resourcing contingency or employed workers
  • Choose which services to outsource
  • Rapid start-up process
  • Tailored solutions for programme management, timeline tracking, and billing

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