Quality

We live in a highly regulated environment, where compliance and quality management are givens. Our world-class team brings to the job nearly 40 combined years of US and international experience in pharmaceutical and biotech manufacturing and testing, medical devices, and product development.

We develop, manage, and validate quality systems including Part 11 compliance, foreign CMO oversight and batch record review, GLP studies, GXP training and documents, GCP site audits, EDC / RDC data verification, supplier qualification, SOPs, GMP training, and FDA / European global requirements. Expert at quality and audits, our team delivers outstanding due diligence for clinical trial sites, laboratories, suppliers, distributors, CROs, and manufacturers in the US, Europe, and Canada.

aktaPD®’s quality assurance teams are specialists in designing a plan for:

  • GCP, GMP, GLP, GDP audits and training
  • 21 CFR part 11 compliance, and Trial Master File and SOP / QA procedures development
  • CAPA
  • Change control
  • Deviations
  • Disaster recovery
  • Documentation
  • Due diligence (labs, suppliers, manufacturers, distributors, CROs, study trial sites)
  • Method development / qualification
  • Quality manual
  • Review and final release
  • Receipt inspection
  • Scale-up and tech transfer
  • Out of specification (OOS)
  • Validation (CSV, GAMP, method, process)

Interested in a smart approach to QC that complies with the latest regulatory and quality standards? Contact us.