Compliance Solutions

Our Compliance professionals have decades of experience designing, training, implementing, and auditing compliance programs in the areas of quality systems and risk management, and can perform gap assessments for compliance with pharmaceutical, biotechnology, and medical device industry regulations (FDA, MHRA, EMA, KFDA). We work to optimize your state of compliance.

  • Inspection Readiness and Support
  • Mock-FDA Inspection
  • GxP Compliance Audits
  • Quality Systems Gap Assessment
  • Supplier Audits and Qualification
  • Computer System/Software Validation
  • Facility Compliance Review/Consulting
  • Commissioning and Qualification
  • Warehousing and Cold Chain
  • SOP Assessment and Writing
  • Training and Education in GxP (GMP, GLP, GCP)
  • Training Course Development and Delivery