9/24/20 Leaderboard Pharma

5K Pharma Consulting LLC

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7073 Violet Veil Ct
Dublin, OH 43016
Phone: click for phone
About 5K Pharma Consulting LLC
  • Consulting services to pharmaceutical industry with focus on compliance and strategic process optimization in QA, QC, and Production. Services include:
    Pharmaceutical Quality Management System
    - Establishment, review, and improvement of the PQMS.
    - Auditing and preparation for inspections.
    - Remediation and process improvement work.
    - Applied experience in areas of US-FDA, EU-EMA, South Am.-ANVISA.
    - General Quality Assurance and documentation.
    Quality Control
    - Method transfer, Optimization, QbD and PAT.
    - Laboratory management and data integrity.
    - Analytical work and release within operations.
    Production - Manufacturing and Packaging
    - Production process optimization and launch readiness.
    - Production systems, problem solving, and efficiency increases.
    - Product development and transfer from R&D to production.
    Project Management
    - PMO and project oversight, operational excellence
    - Product transfer and launches

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Products by 5K Pharma Consulting LLC
  • Pharmaceutical Quality Management System

    Consulting Service in PQMS: - Establishment, review, and improvement of the PQMS. - Auditing and preparation for inspections - Audit management and back-office support. - Internal audits and supplier audits. - Remediation and process improvement work. - Support in main regulatory areas of... Read More