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MULTI-FACETED EXPERTISE

  • Executive Leadership with Multi-Faceted Pharma Expertise

  • Analytical R&D, QC, Reference Standards and Stability

  • API, Solid and Liquid Oral Dosages, Sterile Products

  • cGMP Laboratory Implementation, Compliance, Remediation

  • Analytical Organizational Development and Restructure

  • Extensive Knowledge of cGMP Manufacturing Operations

  • Problematic Product and Manufacturing Process Investigations/Remediation

  • CMC Sections for IND, NDA ANDA, and DMF Regulatory Filings

  • cGMP requirements, OOS, CAPA, Deviations, and Investigations

  • Strategic Planning and Corporate Goals

  • Operational Due Diligence for Corporate Acquisitions

  • Analytical Chemistry Expert Witness

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