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EMA Launches Phased Reviews; Why GMP Submission Strategies Must Change

The European Medicines Agency (EMA) has started a phased review of daraxonrasib, an investigational therapy for metastatic pancreatic cancer. However, the biggest story is not the medicine itself. Instead, the review marks one of the first real-world applications of a
  • News
EMA Launches Phased Reviews; Why GMP Submission Strategies Must Change

Pharmaceutical Warehouse in 2026: GMP Storage Requirements and Inspection Readiness

Discover how compliant pharmaceutical storage supports product quality, regulatory compliance, and inspection readiness. This guide explains warehouse controls, temperature mapping, environmental monitoring, cold chain management, and practical strategies that help reduce inspection findings while maintaining product integrity throughout the supply
  • Blog, Validation and Qualification

Regulatory Compliance Consulting in 2026: FDA, EMA, and Regulatory Affairs

Discover how pharmaceutical regulatory consulting helps organizations eliminate common GMP compliance gaps, improve FDA Compliance and EMA Compliance, implement ICH Guidelines, strengthen regulatory strategy, and achieve greater inspection readiness for successful global market authorization.
  • Blog, Quality Management System
Infographic illustrating common GMP inspection gaps, including documentation, CAPA, data integrity, change control, and risk management that support regulatory consulting services, FDA Compliance, EMA Compliance, and ICH Guidelines.

FDA Finds Gaps in Genzyme’s Data Integrity Program; Warning Letter Cites Discarded Review Records

The FDA has issued a warning letter to Sanofi’s Genzyme manufacturing facility in Waterford, Ireland, after identifying significant weaknesses in Data Integrity and quality management during an inspection. The agency found deficiencies in laboratory record reviews, traceability, and deviation handling
  • News
FDA Finds Gaps in Genzyme's Data Integrity Program; Warning Letter Cites Discarded Review Records

US Reshoring Looks Promising; GMP Validation Could Be the Real Bottleneck

New analysis suggests that pharmaceutical tariffs alone may not achieve the reshoring goals many policymakers expect. According to legal and industry experts in the United States, the economics of generic drug manufacturing, combined with GMP compliance costs and validation requirements,
  • News
US Reshoring Looks Promising; GMP Validation Could Be the Real Bottleneck

Manufacturing Readiness Is Reshaping Pharma M&A; Why GMP Due Diligence Now Drives Deal Decisions

Pharmaceutical dealmaking slowed during the first half of 2026, yet industry experts say transaction quality has become more important than volume. Speaking with Pharmaceutical Technology, KPMG US Life Sciences Sector Leader Kristin Ciriello Pothier explained that manufacturers now place greater
  • News
Manufacturing Readiness Is Reshaping Pharma M&A; Why GMP Due Diligence Now Drives Deal Decisions

Jaypirca Wins CHMP Support; Why Europe Is Moving Toward All-Line CLL Treatment

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Eli Lilly’s Jaypirca (pirtobrutinib) for approval to treat adults with chronic lymphocytic leukemia (CLL) across all lines of therapy, regardless of previous BTK inhibitor treatment. The
  • News
Jaypirca Wins CHMP Support; Why Europe Is Moving Toward All-Line CLL Treatment

Quality Manager Requirements in 2026: Quality Systems Ownership, GMP Compliance, and CAPA Control

This article explains the evolving role of a GMP Quality Manager in pharmaceutical operations, focusing on quality system ownership, CAPA management, deviation investigations, and FDA inspection readiness. It highlights key competencies required for effective pharmaceutical quality management systems today.
  • Blog, Quality Management System
GMP quality assurance manager role in pharmaceutical manufacturing showing quality system ownership, CAPA ownership, deviation investigation process, change control oversight, and quality metrics in GMP operations.

QMS Implementation in 2026: GMP Compliance Failures and Regulatory Inspection Risks

This article explains how QMS Implementation in 2026 strengthens GMP inspection readiness by improving CAPA effectiveness, data integrity compliance, and change control management. It also highlights how pharmaceutical quality systems reduce FDA inspection findings and ensure regulatory compliance stability across
  • Blog, Quality Management System
Pharmaceutical quality system model showing CAPA effectiveness, data integrity compliance, and change control management aligned with GMP inspection readiness and ICH Q10 principles

Pharma Quality Management in 2026: GMP Systems, Risks, and Compliance Frameworks

This article explores the pharma quality management system, focusing on GMP compliance frameworks, quality risk management, CAPA effectiveness, and data integrity. It explains how modern pharmaceutical organizations build resilient quality systems to ensure inspection readiness and regulatory performance in highly
  • Blog, Quality Management System
Pharmaceutical quality management system in the pharmaceutical industry showing GMP compliance framework, quality risk management, CAPA system, data integrity, and continuous improvement within a digital biotech manufacturing environment.