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ISO 9000 in Pharma Industry in 2026: QMS Principles, ISO 9001, GMP Alignment and Implementation Guide

Explore how ISO 9000 principles support pharmaceutical quality systems, strengthen GMP compliance, and connect with ISO 9001 and ICH Q10. Learn how quality teams can apply process-based management, risk-based decisions, and continual improvement to build inspection-ready operations.
  • Blog, Quality Management System
Pharmaceutical quality management system showing GMP compliance, process approach, quality controls, and continual improvement across regulated manufacturing operations.

Thermo Fisher Sees 15–20% India Customer Growth; Global-Standard Labs Drive Demand

Thermo Fisher Scientific expects its customer base in India to grow by 15% to 20% over the next five years as biopharma research and manufacturing expand across the country. The company also forecasts continued double-digit growth, driven by rising demand
  • News
Thermo Fisher Sees 15–20% India Customer Growth; Global-Standard Labs Drive Demand

FDA OAI Forces Novo Site Out; Apitegromab Approval Path Shifts to Backup Facility

Scholar Rock will remove Novo Nordisk’s Bloomington, Indiana fill-finish facility from its apitegromab FDA application after the FDA classified an April 2026 inspection as Official Action Indicated (OAI). FDA review will now continue through a second U.S. fill-finish site. The
  • News
FDA OAI Forces Novo Site Out; Apitegromab Approval Path Shifts to Backup Facility

ISO 9001 in Pharma Industry in 2026: Requirements, GMP Compliance, ICH Q10, and Certification Guide

Explore how ISO 9001 certification supports pharmaceutical quality management, complements GMP compliance and ICH Q10, and strengthens risk management, CAPA, documentation, and continual improvement. Learn what auditors review and which evidence matters most during quality-system assessments.
  • Blog, Quality Management System
Pharmaceutical quality management system showing GMP compliance, quality risk management, CAPA, and inspection-ready documentation.

EMA Updates Shortage Plans; MAHs Get Just Two Days to Respond

The European Medicines Agency (EMA) has updated its guidance on shortage prevention plans for medicines marketed in the EU, ahead of new legal requirements expected by mid-2027. The update matters because marketing authorisation holders (MAHs) must identify supply-chain vulnerabilities, classify
  • News
EMA Updates Shortage Plans; MAHs Get Just Two Days to Respond

FDA Approves Moderna’s mRNA Flu Vaccine; Phase IV Now Determines Senior Evidence

The FDA approved Moderna’s mFlusiva on August 6, 2026, making it the first mRNA-based influenza vaccine authorized in the United States. The agency granted traditional approval for adults aged 50 to 64 but used accelerated approval for those 65 and
  • News
FDA Approves Moderna’s mRNA Flu Vaccine; Phase IV Now Determines Senior Evidence

FDA Rejected Tudriqev Twice; Accelerated Approval Shifts Proof to Phase III

The FDA granted accelerated approval to Replimune’s Tudriqev with nivolumab on August 6, 2026, for advanced melanoma after anti-PD-1 therapy. The decision is significant because FDA had previously rejected the application twice over efficacy concerns. For Regulatory Affairs and clinical
  • News
FDA Rejected Tudriqev Twice; Accelerated Approval Shifts Proof to Phase III

FDA’s Phase 1 CMC Reset; Sponsors Could Save Up to 12 Months

FDA will use an August 6 webinar to explain its proposed Expedited IND Pilot Program, which aims to shorten the path from drug identification to first-in-human trials. The agency wants sponsors to work with qualified research institutions and use rolling
  • News
FDA’s Phase 1 CMC Reset; Sponsors Could Save Up to 12 Months

ICH Guidelines for Pharmacovigilance in 2026: E2A–E2F, ICSR Reporting, PBRER, and Risk Management

Explore how the ICH E2 series connects expedited safety reporting, electronic ICSR transmission, PBRERs, DSURs, and pharmacovigilance planning. This guide also explains regional implementation, inspection evidence, and the controls needed to maintain reliable safety operations.
  • Blog, Quality Management System
Pharmaceutical compliance dashboard showing ICH E2B R3 data exchange, individual case safety reports, periodic benefit-risk evaluation, DSUR preparation, and inspection evidence.

FDA’s Retatrutide Decision; Lilly Could Lose 7 Years of Market Exclusivity

Eli Lilly’s retatrutide biologic dispute with the FDA has reached a critical point before a planned first-quarter 2027 filing. Lilly intends to pursue a Biologics License Application (BLA), while FDA has classified retatrutide as a drug requiring a New Drug
  • News
FDA’s Retatrutide Decision; Lilly Could Lose 7 Years of Market Exclusivity