CONSULTING SERVICES

As a Consultant

With over 35 years of experience in the pharmaceutical and biologics industries, I provide expert consulting services tailored to your organization’s unique challenges. Whether you’re facing regulatory hurdles, operational inefficiencies, or quality system gaps, I deliver practical, sustainable solutions that drive compliance and business growth.

Areas of Expertise:

  • Quality Systems Auditing & Remediation: Conducting cGMP audits, identifying root causes, and implementing corrective actions to ensure compliance with FDA, EMA, and global standards.
  • Interim Controls: Helping companies under Consent Decrees, Warning Letters, or import restrictions achieve compliance and maintain market access by creating interim controls in areas such as batch record review, deviation reviews/backlog reduction and shop floor controls.
  • Retrospective Reviews of deviations and OOS’s: Helping companies assess compliance risk and/or quality system improvements based on a review of past closed deviation investigations.
  • Risk Management & Crisis Resolution: Applying risk-based approaches to resolve operational crises and mitigate regulatory risks.
  • Supply Chain Oversight: Auditing and optimizing the API, excipient, raw material, and 3rd-party manufacturing supply chains for quality and compliance.
  • Operational Excellence: Streamlining processes, improving quality culture, and developing strategies for long-term success.

I work collaboratively with your team, leveraging my expertise to deliver measurable results and build a foundation for sustained compliance and operational efficiency.

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