Quality Assurance & Quality Compliance

Jeiven Pharmaceutical Consulting, Inc. (JPC) helps companies stay compliant with global regulatory requirements through our QA/QC services which include:

  • Audits - Worldwide
    • GMP: Audits of contract manufacturing, testing, packaging and labeling facilities
    • GLP: Laboratory compliance audits, audits of toxicology facilities, studies and reports
    • GCP: Investigator, facility, database, IRB, and study closeout audits
    • DEA: Evaluation of receipt, storage, handling, shipping, security, documentation, and   record keeping
    • QSR: Design History File, quality systems and design controls
    • Pre-Approval Inspection (PAI) preparation

  • Mock Regulatory Audits
    • Preparing your company for regulatory inspections by conducting mock audits
    • Preparing a CAPA  program, if needed

  • Batch Record Review and Product Release
    • Review batch records, including those of your CMO and clinical packaging/labeling   contractor to ensure adherence to GMPs and your protocol. 

  • Monitoring
    • On-site monitoring of manufacturing, testing, packaging and labeling operations

  • Other QA/QC Services
    • Preparation of randomization schedules
    • Stability program management
    • Authoring method development and validation protocols
    • Managing CAPA initiatives

Address :

6 Jacobs Lane
Scotch Plains, New Jersey 07076