FDA Inspection Readiness

FDA Inspection Readiness

Be Prepared for Regulatory Scrutiny​

Preparation for regulatory inspections is the most effective way to avoid delay and be compliant. BioBoston Consulting through its Inspection Readiness services assist clients in preparing and navigating regulatory inspections with confidence. Our former FDA investigators will guide you through mock inspections and interact as they would if it were a real inspection with your team.

Why Choose Us for Inspection Readiness?

Experience and Expertise

Our team of former FDA investigators has vast experience in preparing clients for inspections across several regulatory agencies and jurisdictions.

Comprehensive Preparation

We conduct mock full-scale inspections and gap assessments to reveal improvement areas and ensure clients are prepared against regulatory scrutiny.

Regulatory Insights

We keep ourselves abreast of changing regulatory trends and expectations. We provide insights and guidance that enable our clients to be aligned with requirements.

Confidence Building

We want to instil confidence in the teams of our customers, so that they are best positioned to answer questions from an inspector and can thus demonstrate compliance during inspection.

Our Inspection Readiness Services Include:

  • Mock Inspections and Gap Assessments
  • SOP Review and Development
  • Training for Inspection Readiness
  • Document Management and Organization
  • On-Site Support During Inspections
  • Post-Inspection Follow-Up and Remediation

Ready to Face Inspections with Confidence?

Contact us today to learn more about our Inspection Readiness services and how we can assist you to be prepared for regulatory inspections.

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