Inspection Readiness

FDA inspections can occur with or without advance notice. They can be time-consuming and labor-intensive processes, but they needn’t be frustrating or mysterious if you prepare properly.

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Regulatory authorities expect you to know, understand and comply with all applicable Federal statutes and regulations governing your product development activities. 

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An FDA inspection readiness audit will:

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  • Establish which specific Federal statutes and regulations apply to your business

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  • Evaluate the extent to which your business complies with those statutory obligations, identifying  critical, major and minor compliance gaps and risks that would complicate your FDA inspection

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  • Identify the ways and means by which your compliance issues may be remediated, bringing your business back into compliance

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  • Prepare you for hosting an FDA inspection

Pharmacovigilance

Pharmacovigilance audits assess the capabilities, performance and compliance of vigilance services conducted by your business.

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Pre-approval vigilance audits evaluate both the product safety compliance, as represented in marketing applications under review, along with your company's operational readiness for, and compliance with, the statutory obligations that come with commercial product vigilance requirements.

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These audits can guide your business through the development and implementation stages of pharmacovigilance planning – including the preparation of supportive written procedures (SOPs).  For clients that plan to outsource their commercial vigilance responsibilities, my consulting approach emphasizes the critical mass of corporate staff, along with operational policies, needed to effectively manage vigilance outsourcing partners while minimizing compliance and quality risks for your business.

Due Diligence

Pharmaceutical, biological and medical device product due diligence services bring a regulatory compliance and quality assurance risk management approach to your financial investments and licensing opportunities.

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  • Corporate/Product Regulatory Status

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  • Intellectual Property/Technology Transfer

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  • Products Under Development

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  • Submitted/Approved Marketing Applications

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  • Regulatory Authority Correspondence

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  • Pre- and Post-Approval Vigilance Compliance

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  • Product Complaint Files

Compliance Audits

Planning and conduct of GxP and quality systems audits to assure compliance with FDA regulations and harmonized international guidance documents.

 

  • Submission audits

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  • Sponsor audits

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  • Investigator Site audits

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  • Vendor/Contract Service Provider audits

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  • Quality Systems audits

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  • 21 CFR Part 11 audits

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  • GxP audits

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