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Understanding Compounding Guidelines in Pharmaceutical Practice

Understanding Compounding Guidelines in Pharmaceutical Practice

Understanding Compounding Guidelines in Pharmaceutical Practice ...more

Therapeutic Goods Administration ,GMP

December 09, 20244 min read

The Critical Role of Compliance in Product Commercialization

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, 20245 min read

Calibration and Testing Laboratories: Understanding ISO 17025

Calibration and Testing Laboratories: Understanding ISO 17025

Calibration and Testing Laboratories: Understanding ISO 17025 ...more

Therapeutic Goods Administration ,Good Manufacturing Practices

November 05, 20246 min read

Your Australian Regulatory Compliance Specialists Supporting Therapeutic Goods Manufacturers

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, 20246 min read

Achieving Business Transformation through Regulatory Compliance

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, 20246 min read

Medtech and the Reprocessing of Reusable Medical Devices

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, 20246 min read

Product and Process Development in Pharmaceuticals and Medical Devices: Key Considerations

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, 20246 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

A Detailed Overview of Clinical Quality Management Systems (CQMS) in the Life Sciences Industry ...more

Therapeutic Goods Administration ,GMP &QMS

October 01, 20246 min read

Enhancing and Refining the Regulation of Artificial Intelligence (AI)

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, 20246 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

Influencing Top Management for Compliance: How to Talk to Senior Leaders and Get Results ...more

Therapeutic Goods Administration ,Leadership Values &GMP

September 16, 202410 min read

Compliance as a Business Enabler: A Strategic Approach

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, 20245 min read

How does the TGA regulate therapeutic goods?

How does the TGA regulate therapeutic goods?

How the TGA Regulates Therapeutic Goods in Australia ...more

Therapeutic Goods Administration

September 02, 20245 min read

QSN: Your Australian Regulatory Compliance Specialist in Medicinal Cannabis

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, 20245 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

Ensuring Compliance with Australian TGA Requirements in the Release for Supply Process ...more

Therapeutic Goods Administration ,Quality Training

June 30, 20244 min read

Good Manufacturing Practice (GMP) Made Simple for Therapeutic Manufacturers

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, 20245 min read

Working with the Therapeutic Goods Administration (TGA)

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, 20244 min read

The URPTG Version 2.4 What has changed?

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, 20244 min read

PIC/S Annex 13 for Manufacture of Investigational Medicinal Products – Details on What’s New With Version 16

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, 202411 min read

Review of the Essential Principles Checklist Medical Devices Update

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, 20245 min read

TGA Adopt PIC/S Guide to GMP Version 16  Impact of Annex 16 Authorised Person and Release for Supply

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, 202411 min read

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