LATEST NEWS

Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025

Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025

Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025 ...more

Therapeutic Goods Administration ,News

October 13, 20253 min read

Compliance Isn’t a Cost Center, It’s Your Launch Strategy

Compliance Isn’t a Cost Center, It’s Your Launch Strategy

When you’re ready to scale or license your innovation, buyers and investors want one thing: regulatory assurance. ...more

Compliance

October 12, 20255 min read

Public Feedback sought on updates to Good Manufacturing Practice (GMP) Guidelines

Public Feedback sought on updates to Good Manufacturing Practice (GMP) Guidelines

The Therapeutic Goods Administration (TGA) has opened public consultation on proposed updates to the Good Manufacturing Practice (GMP) guidelines that regulate the manufacture of therapeutic goods in ... ...more

GMP

October 08, 20257 min read

A Startup’s Guide to Regulatory and Commercial Readiness

A Startup’s Guide to Regulatory and Commercial Readiness

For many startups, the steepest learning curve lies not in the innovation itself—but in understanding and meeting the rigorous expectations of regulators such as the Therapeutic Goods Administration (... ...more

Compliance

October 05, 20257 min read

Understand What Is the Risk Management Plan (RMP) and Risk Management File (RMF)

Understand What Is the Risk Management Plan (RMP) and Risk Management File (RMF)

Risk Management Plan (RMP) and the Risk Management File (RMF). Although closely related, they serve different but complementary purposes. Understanding how these fit into your broader quality and regu... ...more

Quality Culture

October 01, 20257 min read

Companies With Strong Quality Cultures Resolve Issues 25% Faster

Companies With Strong Quality Cultures Resolve Issues 25% Faster

Research and practical experience show that companies with strong quality cultures consistently resolve issues up to 25% faster than those without. ...more

Quality Culture

September 29, 20256 min read

Case Study: Establishing ISO 13485 and ISO 14971 Compliance

Case Study: Establishing ISO 13485 and ISO 14971 Compliance

Case Study: Establishing ISO 13485 and ISO 14971 Compliance in a New Medical Device Manufacturing Facility ...more

ISO13485 Certification

September 23, 20255 min read

ISO 14971: Application of Risk Management to Medical Devices

ISO 14971: Application of Risk Management to Medical Devices

ISO 14971: Application of Risk Management to Medical Devices ...more

Quality Culture ,GMP

September 21, 20256 min read

Australian Requirements for GMP Clean Rooms

Australian Requirements for GMP Clean Rooms

Australian Requirements for GMP Clean Rooms ...more

Good Manufacturing Practices

September 16, 20255 min read

How Risk Impacts Medicine Supply in Australia

How Risk Impacts Medicine Supply in Australia

How Risk Impacts Medicine Supply in Australia ...more

Therapeutic Goods Administration ,Medtech

September 14, 20256 min read

Complying with ALCOA++ Principles

Complying with ALCOA++ Principles

Complying with ALCOA++ Principles ...more

Quality Culture ,Compliance

September 10, 20256 min read

Navigating the Release for Supply (RFS) Process Effectively

Navigating the Release for Supply (RFS) Process Effectively

Navigating the Release for Supply (RFS) Process Effectively ...more

GMP

September 07, 20256 min read

How to respond to a TGA Post Inspection Letter (PIL)

How to respond to a TGA Post Inspection Letter (PIL)

How to respond to a TGA Post Inspection Letter (PIL) ...more

Therapeutic Goods Administration ,Compliance

September 03, 20256 min read

Key Updates and Strategic Implications of the Draft EU GMP Chapter 4 Documentation

Key Updates and Strategic Implications of the Draft EU GMP Chapter 4 Documentation

Key Updates and Strategic Implications of the Draft EU GMP Chapter 4 Documentation ...more

GMP

September 01, 20255 min read

What the New Chapter 4 Means for GMP Documentation

What the New Chapter 4 Means for GMP Documentation

What the New Chapter 4 Means for GMP Documentation ...more

News ,GMP

August 27, 20254 min read

What the Revised Annex 11 Means for Computerised Systems in GMP

What the Revised Annex 11 Means for Computerised Systems in GMP

What the Revised Annex 11 Means for Computerised Systems in GMP ...more

GMP

August 25, 20254 min read

Updates on TGA Public Consultation for GMP Guidelines

Updates on TGA Public Consultation for GMP Guidelines

Updates on TGA Public Consultation for GMP Guidelines: Ensuring Relevance in a Technologically Evolving Industry ...more

GMP

August 18, 20255 min read

TGA Clarifies and Strengthens AI and Medical Device Software Regulation

TGA Clarifies and Strengthens AI and Medical Device Software Regulation

TGA Clarifies and Strengthens AI and Medical Device Software Regulation ...more

Therapeutic Goods Administration ,News

August 17, 20256 min read

Just Got Your Grant or Seed Funding? Don’t Spend It All on R&D

Just Got Your Grant or Seed Funding? Don’t Spend It All on R&D

Just Got Your Grant or Seed Funding? Don’t Spend It All on R&D ...more

News ,GMP

August 11, 20255 min read

Ready For Inspections: Validating Lab Systems and Data

Ready For Inspections: Validating Lab Systems and Data

Ready For Inspections: Validating Lab Systems and Data ...more

Quality Culture ,QMS

August 10, 20255 min read

GMP Readiness Made Simple

GMP Readiness Made Simple

GMP Readiness Made Simple ...more

Good Manufacturing Practices ,GMP

August 06, 20255 min read

Surviving the Compliance Cliff

Surviving the Compliance Cliff

Surviving the Compliance Cliff ...more

Compliance

August 03, 20255 min read

The Role of Documentation in GMP Compliance

The Role of Documentation in GMP Compliance

The Role of Documentation in GMP Compliance ...more

Procedures and Policies ,Document Writing

July 30, 20255 min read

Cultural Excellence in Pharma

Cultural Excellence in Pharma

Cultural Excellence in Pharma ...more

Quality Culture

July 28, 20256 min read