In today’s highly regulated life sciences environment, achieving and maintaining compliance with FDA, EMA, ICH, and global regulatory standards is critical. Non-compliance can lead to delayed product launches, costly remediation, or even market withdrawal. BioBoston Consulting offers Custom Gap Assessment Programs designed to identify compliance gaps, mitigate risks, and prepare your organisation for successful inspections worldwide.
Why Global Regulatory Compliance Gap Assessments Matter
Life sciences companies operate in a complex international regulatory ecosystem, covering GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), GLP (Good Laboratory Practice), and GCP (Good Clinical Practice) requirements. Each regulatory body—from the FDA in the United States to the EMA in Europe has distinct expectations and inspection criteria.
A Custom Gap Assessment Program ensures your organisation not only meets the core requirements but also addresses nuanced differences between regions, avoiding regulatory delays and improving operational readiness.
Our Tailored Gap Assessment Methodology
At BioBoston Consulting, we do not believe in one-size-fits-all audits. Our experts design custom gap assessment frameworks based on your operational scope, therapeutic focus, and market goals. This tailored approach allows us to:
- Benchmark Current Compliance Levels against FDA, EMA, MHRA, PMDA, and WHO standards.
- Identify Gaps in Processes, Documentation, and Training before they become critical findings.
- Develop Targeted Remediation Plans that prioritise high-risk areas.
- Align Global Compliance Strategies to meet multi-jurisdictional requirements.
Key Areas Covered in Our Global Gap Assessments
Our Custom Gap Assessment Programs span the entire life sciences compliance spectrum, including:
- GMP Compliance – Manufacturing processes, facility readiness, and quality systems.
- GDP Compliance – Storage, transport, and distribution integrity across supply chains.
- GLP Compliance – Preclinical laboratory operations and data management.
- GCP Compliance – Clinical trial conduct, investigator oversight, and subject safety.
- Data Integrity and Documentation – Ensuring ALCOA+ principles are applied globally.
- Regulatory Submission Readiness – Preparing for FDA, EMA, and local authority reviews.
Benefits of Choosing BioBoston Consulting
Partnering with BioBoston Consulting for your Global Gap Assessment offers multiple advantages:
- Regulatory Intelligence – Our consultants stay ahead of evolving international regulations.
- Inspection Readiness – Confidence in facing FDA, EMA, or other regulatory body audits.
- Cost-Efficient Compliance – Avoid expensive delays and corrective actions.
- Global Harmonisation – Streamlined processes that meet multi-country requirements.
Proactive Compliance for a Competitive Edge
In an industry where speed to market and compliance excellence can make or break success, waiting until the last minute to address regulatory gaps is a costly risk. By engaging BioBoston Consulting’s Custom Gap Assessment Programs, you ensure your organisation is inspection-ready across all jurisdictions, avoiding unexpected findings and protecting your market position.
Secure Your Compliance Future Today
Whether you are preparing for an FDA inspection, EMA audit, or seeking to align with global GMP, GDP, GLP, and GCP standards, BioBoston Consulting has the expertise to guide you every step of the way.
📩 Contact BioBoston Consulting today to schedule your Custom Gap Assessment Program and safeguard your compliance across global markets.