Articles tagged with “fda-guidance”

FDA CSA Guidance: A Pharma & Biotech Compliance Guide

Understand the FDA's final Computer Software Assurance (CSA) guidance, a risk-based shift from CSV for pharma & biotech. Learn key principles for compliance.

30 min read

12/27/2025

computer software assurance fda guidance software validation gxp compliance risk-based validation pharma manufacturing 21 cfr part 11

GAMP 5 & CSA: A Practical Integration Guide for Pharma

Learn how to integrate GAMP 5 (2nd Ed.) and Computer Software Assurance (CSA). This guide details the shift from CSV to a modern, risk-based validation strategy

40 min read

12/26/2025

gamp 5 computer software assurance csa risk-based validation pharma it gxp compliance fda guidance

AI for IND & CTA Drafting: Benefits, Risks & Compliance Guide

Learn how generative AI and LLMs assist in drafting pharma IND & CTA submissions. This guide explains the benefits, risks, GxP compliance, and FDA/EMA guidance.

60 min read

12/9/2025

generative ai regulatory affairs ind submission cta submission medical writing llms in pharma gxp compliance drug development fda guidance

Writing a Target Product Profile (TPP) for Drug Development

A guide to the Target Product Profile (TPP), a strategic document for drug development. Learn its components, purpose, and how to align it with the final drug l

40 min read

11/24/2025

target product profile tpp drug development drug labeling regulatory affairs fda guidance clinical development regulatory strategy

Adaptive Trial Design: A Guide to Flexible Clinical Trials

An in-depth guide to adaptive trial design. Learn how prespecified changes based on interim data can make clinical trials more efficient and ethical.

45 min read

11/22/2025

adaptive trial design clinical trials master protocol platform trials biostatistics interim analysis fda guidance sample size re-estimation

Managing Protocol Deviations: A Guide for Clinical Trials

Learn how to manage protocol deviations in clinical trials. This guide covers classification, reporting, and prevention to ensure data integrity and GCP complia

40 min read

11/20/2025

protocol deviation clinical trials good clinical practice (gcp)data integrity fda guidance protocol compliance ich guidelines protocol violation

ALCOA+ Principles: A Guide to GxP Data Integrity

Learn the 9 ALCOA+ principles for GxP data integrity. This complete guide explains each attribute, FDA & EMA regulations, and compliance for pharma and life sci

50 min read

10/31/2025

alcoa+data integrity gxp fda guidance ema good manufacturing practice 21 cfr part 11 regulatory compliance

AI Medical Devices: 2025 Status, Regulation & Challenges

Analysis of AI medical devices in 2025. Learn about market growth, 950+ FDA-cleared devices, new regulations like the EU AI Act, and key clinical challenges.

50 min read

10/30/2025

ai medical devices medical device regulation software as a medical device fda guidance eu ai act ai in healthcare algorithmic bias

Clinical Trial Phases 1–3: A Comprehensive Guide for Pharmaceutical IT Professionals

A practical guide to clinical trial phases 1–3 for pharma IT: objectives, compliance, costs, and IT infrastructure for modern drug development.

20 min read

5/14/2025

clinical trial phases pharma IT regulatory compliance EDC CTMS FDA guidance GCP CDISC drug development