Quality & Compliance

We help our clients achieve and maintain compliance with regulatory requirements, including FDA Good Manufacturing Practice (GMP) regulations, Quality Systems Regulation (QSR), Good Laboratory Practice (GLP) regulations, Good Clinical Practice (GCP) rules and guidelines (FDA/ICH), and ISO 9000 and other ISO standards. Our services include, but are not limited to:

Application and Submission

  • Preparation of Submissions – DMF, CTD
  • FDA Liaison

Non-Clinical

  • Study Monitoring/GLP Audits

Clinical

  • Assist with FDA’s GCP Requirements
  • GCP Audits/Monitoring
  • Data Integrity Audits

CMC Development

  • Drug Substance Report and Preparation
  • Drug Product Report and Preparation

Quality Assurance/Quality Control

  • Policy and Procedures