Pharmaceutical Industry Articles & Reports - Page 6

Learn what must be included in a pharma quality agreement. This guide covers key clauses, sponsor vs. CDMO responsibilities, and GMP regulatory requirements fro

Learn the fundamentals of pharmaceutical stability programs. This guide covers study design, execution, and data trending per ICH & FDA guidelines to set shelf

Understand analytical method validation with this deep dive into ICH Q2(R2). Explore validation parameters, documentation, and the new QbD lifecycle approach wi

Learn the lifecycle approach to biotech process validation. This guide covers PPQ and CPV planning, execution, and monitoring based on FDA, EMA, and ICH guidanc

An educational guide to generic drug patent challenges. Learn about the Hatch-Waxman Act, the ANDA pathway, Paragraph IV certifications, and the FDA Orange Book

Learn how pharma companies compliantly fund physician education via unrestricted grants. Explore ACCME standards, the Sunshine Act, and firewalls for ethical CM

Learn how Process Analytical Technology (PAT) uses sensors like NIR & Raman for real-time reaction monitoring in pharmaceutical manufacturing to improve quality

Learn how Quality by Design (QbD) and IT systems are shifting pharma from end-product testing to real-time quality assurance with PAT and data analytics.

Learn the economic principles behind million-dollar gene therapy pricing. This analysis compares one-time cure costs to lifetime chronic care using value-based

Analysis of how Large Language Models (LLMs) automate clinical evidence collection for HTA economic dossiers. Covers systematic reviews, data extraction, and ch

Learn how patient quality of life (QoL) data is quantified into Quality-Adjusted Life Years (QALYs) to perform cost-effectiveness analysis for specialty drugs.

Learn how real-world data (RWD) and evidence (RWE) are used to validate clinical trial assumptions in post-market economic models for HTA and reimbursement.

Learn how health economic data like cost-effectiveness analysis is used to secure drug formulary placement and reimbursement from payers and HTA bodies.

Learn the integrated workflow for manufacturing deviations, CAPA, and change control in GMP. This guide covers regulatory requirements and common inspection pit

An educational guide to biologics comparability studies. Learn how to prove "no meaningful change" after manufacturing process changes, based on ICH Q5E and FDA

Learn how Integrated Business Planning (IBP) and S&OP help pharma supply chains align demand, capacity, inventory, and constraints to improve forecast accuracy.

Learn how MES and Electronic Batch Records (EBR) improve pharma manufacturing. This guide explains benefits for GMP compliance, data integrity, and review-by-ex

Learn the key differences between US DSCSA and EU FMD for pharmaceutical serialization. This guide covers compliance requirements for ops teams, including data

Learn a proven framework for CDMO selection in pharma and biotech. This guide covers a data-driven process using scorecards, due diligence, and governance KPIs.

Learn the critical steps for successful pharmaceutical technology transfer. This guide covers the R&D to CDMO process, key documents, and how to avoid scale-up

Get a technical playbook for the Veeva CRM to Vault CRM migration. This guide for IT teams covers data mapping, integrations, GxP validation, and a step-by-step

Learn to validate AI/ML systems in GxP manufacturing using the GAMP 5 Appendix D11 framework. Explore key considerations for data integrity, risk, and model dri

Learn to deploy private LLMs in pharma. This guide covers compliant architecture, including on-premise & cloud, and navigating HIPAA, GxP, and FDA regulations.

Learn how Generative AI (GenAI) applies to Medical Affairs in pharma. This guide covers key use cases, compliance guardrails, and the risks of using LLMs.