Category: Uncategorised

Accelagen Exhibiting at Ausbiotech + Invest 2020!

September 3, 2020
Accelagen is proud to announce it will be exhibiting at the virtual Ausbiotech + Invest 2020 Conference occurring on 28 – 30 October. Ausbiotech will be delivering a brand-new live and on-demand digital platform! Accelagen is excited to participate in this fresh and dynamic virtual event. Despite the COVID-19 pandemic across the world, we have

Sarah Henderson joins the Plunkett Consulting team!

June 21, 2016
Plunkett Consulting is pleased to announce the addition of Sarah Henderson to the Regulatory team. Sarah has recently returned to Australia after period working in the United Kingdom for Actavis (recently acquired by Teva Pharmaceutical Industries). There she gained experience and knowledge in working in the European regulatory field (including in National and Mutual Recognition/Decentralised

Collaboration with Centre for Eye Research Australia

January 27, 2016
Plunkett Consulting is pleased to announce a new collaboration with the Centre for Eye Research Australia (CERA). CERA, based at Melbourne’s Royal Victorian Eye and Ear Hospital, is the leading eye research centre in Australia and is dedicated to translating scientific research to better treatments, earlier diagnosis and disease prevention.  Through this collaboration, Plunkett Consulting

Approval of Orphan Drug Designation application

February 11, 2015
Plunkett Consulting, on behalf of our international client, has been assigned Orphan Drug Designation by the Therapeutic Goods Administration (TGA) for a new treatment malignant pleural mesothelioma currently in development. As part of  this collaboration, Plunkett Consulting has prepared and submitted a comprehensive Orphan Drug Designation application to the TGA, that provides a detailed overview

Chris Rolls joins the team at Plunkett Consulting

September 24, 2014
Plunkett Consulting is pleased to welcome the addition of Chris Rolls to its regulatory consulting team. Chris Rolls recently finished up with the Therapeutic Goods Administration (the Australian National Regulatory Authority) in August 2014 after 26 years of vaccine regulation, and is now working with Plunkett Consulting to continue to provide regulatory and quality assurance

Plunkett Consulting launches Tournistrip® disposable single-use tourniquet in Australia

March 5, 2014
Plunkett Consulting is pleased to announce it has entered into an agreement for the supply of the disposable tourniquet, Tournistrip®, as manufactured by ASep Healthcare. The Tournistrip® represents a simple and eloquent innovation for a medical tourniquet. The Tournistrip® has supplied extensively in the United Kingdom and its use continues to grow as health professionals

Regulatory Approval for New Airway Management Devices

July 30, 2013
Through a collaboration with Sydney based ASP Healthcare (www.asphealthcare.com.au), Plunkett Consulting has provided regulatory support to obtain regulatory approval for a new range of patient airway devices. The approval of these devices provides ASP Healthcare with a new product range for effective airway management of intubated patients. As part of this project, Plunkett Consulting has

Conformity Assessment Application

August 21, 2012
Plunkett Consulting has successfully assisted an Australian manufacturer lodge their first Conformity Assessment Application for Class IV in vitro diagnostics (IVD). This submission signifies a successful collaboration for the development of a Device Design dossier to demonstrate conformance with the Therapeutic Goods Administration (TGA) Essential Principles of Safety and Performance. Contact us to discover how