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Author: Khyati Patel

EMA and FDA Issue Joint Principles

Pharmacovigilance Services

EMA and FDA Issue Joint Principles on AI in Medicine Development: What It Means for PV Teams

June 11, 2026 No Comments

GDP 2026

Pharma Audits

GDP 2026: Understanding MHRA, DSCSA, and Global Traceability Requirements

June 9, 2026 No Comments

Root Cause Analysis Tools for GxP CAPA

GVP Audits

Root Cause Analysis Tools for GxP CAPA: When to Use Ishikawa, 5-Why and Fault Tree Analysis

June 4, 2026 No Comments

PSMF Maintenance Checklist

Pharma Audits

PSMF Maintenance Checklist: What Needs Updating After a Licence Variation, Product Transfer or MAH Change

June 2, 2026 No Comments

CE Mark vs Device Approvals

Pharmacovigilance Services

CE Mark vs National Device Approvals: How Global Medical Device Manufacturers Should Plan Their Compliance Strategy in 2026

May 28, 2026 No Comments

EMA, FDA and MHRA GMP Annex Revisions

Pharma Audits

EMA, FDA and MHRA GMP Annex Revisions 2026- 2028: What Every Pharma QA Team Must Prepare For

May 26, 2026 No Comments

GMP Mock Inspection

Pharma Audits

GMP Mock Inspection for Pharmaceutical Manufacturers: What Global Regulators Check That Internal Teams Miss

May 21, 2026 No Comments

Regulatory Deficiency

GVP Audits

How to Respond to a Regulatory Deficiency Letter: A Step-by-Step CAPA Guide for Pharmaceutical Sites

May 19, 2026 No Comments

EU QPPV Services

Pharmacovigilance Services

EU QPPV Services: Cost Comparison In-House vs Outsourced QPPV for MAHs in 2026

May 14, 2026 No Comments

Pharmacovigilance Services

End-to-End GxP Quality and Pharmacovigilance Services: Integrated vs Fragmented PV

May 12, 2026 No Comments

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