David Chesney brings 23 years FDA experience and over 26 years world wide GxP consulting experience to help clients assess and optimize their quality assurance and regulatory compliance strategies and governance processes.

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• "GxP" (GMP, GCP, GLP and Pharmacovigilance) compliance strategy and assessments

• Training in GxP topics and FDA inspection readiness

• Assistance with post-FDA inspection communication and remediation of GxP inspection observations

• Evaluation and improvement of quality systems

• Quality organization structure and performance

• Adjunct assistance to legal counsel in sensitive or privileged matters

• Limited Expert Witness services; contact us for details

• See the "Services" tab above for additional information

Quality Assurance and Regulatory Compliance Strategy

In addition to sound scientific judgment, achievement of regulatory compliance objectives requires a strong quality culture, a thoughtful strategy and an effective business governance process.  Proactively, we can help you formulate a strategy and process that best fits your company’s business objectives, regardless of size, stage of product development or therapeutic area.  If problems do arise, we can help design an effective strategy for remediation and prevention of recurrence.

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Client References

We talk to our clients, not about them.  References can be supplied on request, but never without each client’s permission.  You can be assured that we will maintan the same level of respect and confidentiality in our relationship with you.