LATEST NEWS
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, 2025•3 min read
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, 2025•5 min read
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, 2025•7 min read
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, 2025•7 min read
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, 2025•7 min read
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, 2025•6 min read
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, 2025•5 min read
ISO 14971: Application of Risk Management to Medical Devices
ISO 14971: Application of Risk Management to Medical Devices ...more
Quality Culture ,GMP
September 21, 2025•6 min read
Australian Requirements for GMP Clean Rooms
Australian Requirements for GMP Clean Rooms ...more
Good Manufacturing Practices
September 16, 2025•5 min read
How Risk Impacts Medicine Supply in Australia
How Risk Impacts Medicine Supply in Australia ...more
Therapeutic Goods Administration ,Medtech
September 14, 2025•6 min read
Complying with ALCOA++ Principles
Complying with ALCOA++ Principles ...more
Quality Culture ,Compliance
September 10, 2025•6 min read
Navigating the Release for Supply (RFS) Process Effectively
Navigating the Release for Supply (RFS) Process Effectively ...more
GMP
September 07, 2025•6 min read
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, 2025•6 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 ...more
GMP
September 01, 2025•5 min read
What the New Chapter 4 Means for GMP Documentation
What the New Chapter 4 Means for GMP Documentation ...more
News ,GMP
August 27, 2025•4 min read
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, 2025•4 min read
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, 2025•5 min read
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, 2025•6 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 ...more
News ,GMP
August 11, 2025•5 min read
Ready For Inspections: Validating Lab Systems and Data
Ready For Inspections: Validating Lab Systems and Data ...more
Quality Culture ,QMS
August 10, 2025•5 min read
GMP Readiness Made Simple
GMP Readiness Made Simple ...more
Good Manufacturing Practices ,GMP
August 06, 2025•5 min read
Surviving the Compliance Cliff
Surviving the Compliance Cliff ...more
Compliance
August 03, 2025•5 min read
The Role of Documentation in GMP Compliance
The Role of Documentation in GMP Compliance ...more
Procedures and Policies ,Document Writing
July 30, 2025•5 min read
Cultural Excellence in Pharma
Cultural Excellence in Pharma ...more
Quality Culture
July 28, 2025•6 min read