What Is a Gap Assessment and Why It Matters
In regulated industries, particularly pharmaceuticals, biologics, medical devices, and 503B outsourcing facilities, a gap assessment is not a formality. It is a strategic diagnostic tool. When done...
503B FDA Inspections: Common Findings and How to Prepare
Why Are 503B Pharmacies Receiving FDA Warning Letters? 503B outsourcing facilities are registered under Section 503B of the FD&C Act and are required to comply with current Good Manufacturing...
Why 503B Pharmacies Are Struggling with FDA Inspections
Over the past several years, inspection outcomes for 503B outsourcing facilities have trended in the wrong direction. The U.S. Food and Drug Administration has issued a steady stream of Form 483...
FDA Warning Letter to Pharmacy: What the Industry Should Learn
On January 16, 2026, the U.S. Food and Drug Administration issued a Warning Letter to Boothwyn Pharmacy, LLC following a 2025 inspection of its sterile compounding operations. For organizations...
How Do You Implement CAPA That Actually Works (and Satisfies Auditors)?
Corrective and Preventive Action (CAPA) is one of the most frequently cited areas in FDA inspections, ISO audits, and notified body reviews. Despite this, many organizations still struggle to...
Can Small or Startup Life Science Companies Be Compliant Without a Full QA Team?
For many early stage life science companies, regulatory compliance feels like a catch-22. Regulators expect robust quality systems, documented processes, and ongoing oversight—yet hiring a full...
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Ensuring Excellence: The Importance of Vendor and Supplier Quality Management for Life Sciences
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Why Hire a Third-Party Consultancy for Quality Assurance
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Navigating the Regulatory Pathway
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Navigating the FDA’s Final Rule for LDTs
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Internal Audits: A Vital Tool for Life Science Companies
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Navigating Regulatory Affairs: Key Questions and Best Practices for Life Science Companies
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