LATEST NEWS

ISO Accreditation Readiness Scorecard

GMP licensing and ISO accreditation are critical milestones for therapeutic goods manufacturers, testing laboratories, and biotechnology companies. A readiness assessment using a structured scorecard ... ...more

ISO Recommendations

December 03, 2025•4 min read

AusBiotech 2025 International Conference

AusBiotech 2025 offered a valuable reflection point for the biotechnology sector, particularly regarding GMP and regulatory compliance. ...more

News ,GMP

December 01, 2025•3 min read

Think You're Ready for Your Next GMP Inspection?

Preparing for a GMP inspection requires a comprehensive, structured approach encompassing quality management systems, documentation, facilities, equipment, personnel, process control, and risk managem... ...more

GMP

November 27, 2025•4 min read

Establishing Readiness for Clinical Trial Manufacturing

Establishing readiness for clinical trial manufacturing is a multidimensional process requiring attention to regulatory compliance, facility and personnel preparedness, quality systems, process valida... ...more

Medtech

November 24, 2025•5 min read

Is Your Warehouse Process Designed for GMP or ISO Compliance?

Warehousing is a critical component of the supply chain for therapeutic goods, biotechnology products, and laboratory materials. ...more

GMP

November 19, 2025•6 min read

What is the Difference Between R&D Documentation and GMP Documentation?

The regulatory environment surrounding R&D documentation is generally less stringent than that governing GMP documentation. ...more

GMP

November 17, 2025•5 min read

GMP Industry News and Developments

New Blog Post Description ...more

GMP

November 12, 2025•4 min read

QMS Gap Assessment and Integration

The QMS gap assessment and integration conducted by QSN demonstrates a comprehensive approach to achieving regulatory compliance in the therapeutic goods sector. ...more

QMS

November 10, 2025•5 min read

GMP Certification Milestones & Global Inspection Activity

GMP certification milestones and global inspection activity are more than regulatory formalities; they represent critical mechanisms for ensuring product quality, patient safety, and corporate credibi... ...more

GMP

November 05, 2025•6 min read

Temporary GMP Exemptions for Bacteriophage Therapies in Australia

The proposed temporary GMP exemption by the TGA for personalised bacteriophage therapy manufacture in Australia marks a significant regulatory development for the emerging phage‑therapy sector. ...more

News

November 02, 2025•6 min read

Case Study: Supporting a Manufacturer Transitioning to ISO 13485 Compliance

This case study demonstrates how Quality Systems Now provides end-to-end support for manufacturers transitioning into medical device production. By combining standards expertise, practical implementat... ...more

Compliance

October 29, 2025•4 min read

New Regulations to Strengthen Medical Device Patient Safety

The introduction of mandatory reporting requirements for medical device-related adverse events marks a significant step forward in enhancing patient safety in Australia. ...more

News

October 26, 2025•4 min read

Understanding the Gaps and Overlaps Between ISO 13485, EU MDR, and MDSAP

ISO 13485, EU MDR, and MDSAP share significant commonalities in quality management, risk control, post-market surveillance, and documentation practices. However, gaps remain in clinical evaluation, UD... ...more

ISO13485 Certification

October 22, 2025•6 min read

General GxP Requirements – GLP, GCP, and GMP

GLP, GCP, and GMP form the backbone of GxP requirements in the life sciences sector. While each framework has a distinct focus—laboratory studies, clinical trials, and manufacturing—they share core pr... ...more

GMP

October 18, 2025•5 min read

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