Identify and Close Compliance Gaps Before FDA Inspections

Proactive Compliance for a Stress-Free FDA Audit

In the highly regulated world of biotechnology, pharmaceuticals, and medical devices, preparation is everything. When it comes to FDA inspections, even small compliance gaps can result in costly delays, warning letters, or enforcement actions.

At BioBoston Consulting, we specialize in helping life sciences organizations identify and close compliance gaps before FDA inspections, ensuring you are audit-ready, compliant, and confident. Our FDA readiness and gap assessment services combine regulatory expertise with a proven methodology to protect your business from compliance risks.

Why Pre-Inspection Gap Assessments Are Critical

The FDA holds life sciences companies to strict Current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) standards. Without regular assessments, hidden gaps can go unnoticed until it’s too late.

Benefits of conducting a pre-inspection gap assessment include:

• Early detection of compliance weaknesses.
• Minimized risk of FDA Form 483 observations or warning letters.
• Faster regulatory approval timelines.
• Protection of your company’s reputation and revenue.

Our Comprehensive Approach to Closing Compliance Gaps

BioBoston Consulting’s FDA inspection readiness services are designed to be both thorough and customized to your unique operations. We focus on identifying and remediating gaps well before regulators arrive.

Our proven process includes:

1. Pre-Assessment Consultation – Understanding your operations, regulatory history, and inspection goals.
2. Documentation & SOP Review – Evaluating policies, procedures, and records for FDA compliance.
3. Operational Walkthroughs – Observing day-to-day practices to identify discrepancies with written procedures.
4. GxP Compliance Checks – Covering cGMP, GCP, GLP, and other applicable standards.
5. Risk Prioritization – Highlighting issues that carry the highest regulatory risk.
6. Remediation Action Plan – Providing actionable solutions with clear timelines.
7. Mock FDA Inspections – Simulating the inspection environment to ensure readiness.

Areas We Assess for FDA Compliance

We leave no stone unturned in our compliance gap assessment, including:

• Manufacturing and Quality Control processes.
• Quality Management Systems (QMS) and documentation control.
• Training and Competency Records for staff.
• Clinical Trial Documentation and data integrity.
• Supplier and Vendor Qualification programs.
• Change Control, CAPA, and Deviation Management.
• Product Development and Tech Transfer Processes.

Why Choose BioBoston Consulting

When it comes to FDA inspection readiness, experience matters.

• Regulatory Expertise – Deep understanding of FDA requirements across biotech, pharma, and medtech.
• Custom Solutions – Tailored gap assessments based on your operations and risk profile.
• Proven Results – Clients have passed FDA inspections with zero major observations after our readiness programs.
• Global Perspective – Experience with international regulations including EMA, MHRA, and WHO guidelines.

Stay Ahead of Regulatory Scrutiny

FDA inspections are becoming more frequent, detailed, and data driven. With global supply chains, evolving standards, and new compliance technologies, proactive preparation is your best defense. Regular gap assessments ensure you stay ahead of changes and maintain inspection readiness year-round.

Your FDA Readiness Starts Now

Do not wait for an FDA investigator to uncover compliance gaps. Take control of your regulatory preparedness today.

Contact BioBoston Consulting to schedule your FDA Inspection Readiness Gap Assessment and safeguard your operations against compliance risks.