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 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

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