Category: News

Orphan Drug Designation: a pathway to accessible treatment for rare diseases

August 18, 2021
The term ‘Orphan Drugs’ refers to medicines developed to treat medical conditions, considered to be rare. In Australia, if a medicine is intended to treat a condition which affects fewer than 5 in 10,000 individuals, it may fit within the definitions of an Orphan Drug. With a low number of patients who may be eligible

Accelagen facilitates LEDAGA Approval in Australia

August 3, 2021
LEDAGA® (Chlormethine hydrochloride) – TGA APPROVAL Accelagen, a Melbourne based Regulatory Affairs, Clinical Research and Development Organisation, are pleased to be an integral part of the approval of LEDAGA® by the Therapeutic Goods Administration (TGA) on behalf of the Australian office of Recordati Rare Diseases. LEDAGA, indicated for the topical treatment of mycosis fungoides-type cutaneous

Accelagen driving development of new candidate for COVID-19 Vaccine

September 1, 2020
1st September 2020 Accelagen is excited to announce the initiation of a new COVID-19 vaccine trial, commencing in Melbourne on Tuesday 1st September! One of the largest vaccine manufacturer’s in the world has entrusted Accelagen to initiate this important first study to support the next stage of development of this novel vaccine. Following the successful

Plunkett Consulting Group to attend BioKorea 2018

April 27, 2018
Plunkett Consulting Group will be attending the BioKorea International Convention  in Seoul during 9 – 11 May 2018.  This is an exciting opportunity to meet with research leaders in Asia and showcase our Company’s capabilities internationally. Really looking forward to a great outcome!

Introducing eCTD Publishing Service

April 27, 2018
Regulatory publishing demands are growing, and soon all submissions must be submitted in electronic CTD (eCTD) format.  In recognising this, Plunkett Consulting Group are excited by the opportunity to add regulatory publishing to our suite of services.  We have access to the Extedo eCTDmanager software that allows us to publish electronic regulatory documentation for not

New Name and New Site – same great service

March 22, 2017
To represent our evolution as a high quality consulting company, Plunkett Consulting Pty Ltd will now be known as the Plunkett Consulting Group.  This new name reflects the collection of great staff who support our local and overseas clients in regulatory affairs and clinical development projects. With the continued expansion of our clinical research capabilities,

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

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