Latest News
The Critical Role of Compliance in Product Commercialization
The Critical Role of Compliance in Product Commercialization ...more
Therapeutic Goods Administration ,Good Manufacturing Practices
November 17, 2024•5 min read
Calibration and Testing Laboratories: Understanding ISO 17025
Calibration and Testing Laboratories: Understanding ISO 17025 ...more
Therapeutic Goods Administration ,Good Manufacturing Practices
November 05, 2024•6 min read
Your Australian Regulatory Compliance Specialists Supporting Therapeutic Goods Manufacturers
Quality Systems Now: Your Australian Regulatory Compliance Specialists Supporting Therapeutic Goods Manufacturers ...more
Therapeutic Goods Administration ,GMP
November 05, 2024•6 min read
Achieving Business Transformation through Regulatory Compliance
Achieving Business Transformation through Regulatory Compliance: Key Strategies for Sustainable Growth ...more
Therapeutic Goods Administration ,Quality Culture &GMP
October 28, 2024•6 min read
Medtech and the Reprocessing of Reusable Medical Devices
Medtech and the Reprocessing of Reusable Medical Devices – AS 4187 / AS 5369 ...more
Therapeutic Goods Administration ,Medtech
October 14, 2024•6 min read
Product and Process Development in Pharmaceuticals and Medical Devices: Key Considerations
Product and Process Development in Pharmaceuticals and Medical Devices: Key Considerations ...more
Therapeutic Goods Administration ,Procedures and Policies &GMP
October 08, 2024•6 min read
A Detailed Overview of Clinical Quality Management Systems (CQMS) in the Life Sciences Industry
A Detailed Overview of Clinical Quality Management Systems (CQMS) in the Life Sciences Industry ...more
Therapeutic Goods Administration ,GMP &QMS
October 01, 2024•6 min read
Enhancing and Refining the Regulation of Artificial Intelligence (AI)
Enhancing and Refining the Regulation of Artificial Intelligence (AI) ...more
Therapeutic Goods Administration ,AI
September 16, 2024•6 min read
Influencing Top Management for Compliance: How to Talk to Senior Leaders and Get Results
Influencing Top Management for Compliance: How to Talk to Senior Leaders and Get Results ...more
Therapeutic Goods Administration ,Leadership Values &GMP
September 16, 2024•10 min read
Compliance as a Business Enabler: A Strategic Approach
Compliance as a Business Enabler: A Strategic Approach ...more
Therapeutic Goods Administration ,Procedures and Policies
September 10, 2024•5 min read
How does the TGA regulate therapeutic goods?
How the TGA Regulates Therapeutic Goods in Australia ...more
Therapeutic Goods Administration
September 02, 2024•5 min read
QSN: Your Australian Regulatory Compliance Specialist in Medicinal Cannabis
The medicinal cannabis industry in Australia is burgeoning, driven by an increasing recognition of its therapeutic potential and a supportive regulatory framework. ...more
Therapeutic Goods Administration ,GMP
September 02, 2024•5 min read
Ensuring Compliance with Australian TGA Requirements in the Release for Supply Process
Ensuring Compliance with Australian TGA Requirements in the Release for Supply Process ...more
Therapeutic Goods Administration ,Quality Training
June 30, 2024•4 min read
Good Manufacturing Practice (GMP) Made Simple for Therapeutic Manufacturers
Good Manufacturing Practice (GMP) is a system designed to ensure products are consistently produced and controlled according to quality standards. ...more
Therapeutic Goods Administration ,Good Manufacturing Practices &GMP
June 12, 2024•5 min read
Working with the Therapeutic Goods Administration (TGA)
In Australia, the Therapeutic Goods Administration (TGA) oversees the quality, safety, and availability of therapeutic products. ...more
Therapeutic Goods Administration
April 25, 2024•4 min read
The URPTG Version 2.4 What has changed?
The rewrite of the URPTG in version 2.4 introduces a streamlined process with a clearer process flow, reducing complexity. ...more
Therapeutic Goods Administration
April 15, 2024•4 min read
PIC/S Annex 13 for Manufacture of Investigational Medicinal Products – Details on What’s New With Version 16
The TGA have announced that version 16 of the PIC/S Guide to GMP will be adopted in Australia from June 2024 ...more
Therapeutic Goods Administration ,News
April 06, 2024•11 min read
Review of the Essential Principles Checklist Medical Devices Update
On 19 February, 2024, the Therapeutic Goods Administration (TGA) updated the Essential Principles checklist (medical devices) template, increasing its length from 23 to 41 pages! ...more
Therapeutic Goods Administration ,News
March 26, 2024•5 min read
TGA Adopt PIC/S Guide to GMP Version 16 Impact of Annex 16 Authorised Person and Release for Supply
This week, the Therapeutic Goods Administration (TGA) announced that they will be adopting version 16 of the PIC/S Guide to GMP on 3rd June 2024 ...more
Therapeutic Goods Administration
March 14, 2024•11 min read