brand-logo

        • Our difference

          Our difference

          Putting people first, our unique approach results in meaningful outcomes that have a tangible impact on the future of human health, co-created with you every step of the way. 

          Our team

          With an experienced and diverse team, Accelagen’s experts blend skills in clinical trials and regulatory affairs management to accelerate your ability to deliver better therapies for patients.

          Australian Advantage

          As a company headquartered in Australia, Accelagen is both locally positioned and globally adept, working with companies big and small to accelerate the future of human health and wellness around the world.

          Careers

          It is an exciting time to be part of Accelagen, as we grow and evolve at a rapid rate. Find out why people are at the heart of what we do and how you can be part of our work to accelerate human health.

          • Go back

          The company

          Get in touch
  • Case studies
  • Get in touch
Get in touch
Get in touch

Conformity Assessment Application

Conformity Assessment Application

Conformity Assessment Application

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 Plunkett Consulting can assist with navigating through the Australian regulatory system.

You might also like...​

Accelagen facilitates LEDAGA Approval in Australia

Accelagen facilitates LEDAGA Approval in Australia 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 […]

Read More
Accelagen driving development of new candidate for COVID-19 Vaccine

Accelagen driving development of new candidate for COVID-19 Vaccine 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 […]

Read More
Conformity Assessment Application

Conformity Assessment Application 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 […]

Read More