Date Posted – 20 May 2021
Accelagen, a Melbourne based Regulatory Affairs, Clinical Research and Development Organisation, has come from humble beginnings and grown into a highly successful, effective and committed Contract Research Organisation (CRO) working with an array of local and international clients.
Founded in 2010, Accelagen’s growth allowed it to expand their services and expertise to facilitate the development of novel pharmaceutical and medical device products from concept to commercialization. Our people’s unique skills and expertise are highly sought by clients seeking the right partner in Australia and have elevated Accelagen to become a CRO of choice.
With a focus on client’s objectives first and foremost, Accelagen deliver strategies to achieve goals in a time and cost-effective way, while minimizing the time required on a project by combining key specialist skills within one organisation.
During the recent COVID-19 pandemic, Accelagen grew stronger, including being asked to deliver critical Phase 1 & 2 studies of novel COVID-19 vaccines intended to be used for the inoculation of low to middle income countries.
Although the industry witnessed a ‘slowdown’ in some areas during the pandemic, Accelagen took the opportunity to expand their team and enhance operational capabilities. Notably, they invested in new technologies to ensure they remained at the forefront of clinical study conduct.
Accelagen has the capabilities to support clients with the transition of assets from pre-clinical evaluation stage into human clinical trials, defining the development strategy and gathering of key data, required to step through the ethical review landscape.
The regulatory team continues to successfully drive product registrations both in Australia and internationally. This includes new therapeutic products and devices, allowing clients to supply life-saving and critical medicines to patients. Importantly Accelagen’s expertise extends beyond Australia, where the team have developed Investigational New Drug (IND) applications to the FDA and Investigational Medicine Product Dossiers (IMPD) for European submissions.
A growing extension to Accelagen’s regulatory expertise is a well-established eCTD dossier publishing service utilizing world leading systems provided through Lorenz. eCTD publishing has become a mainstay, but for many companies the value of introducing and maintaining this as an in-house service is not feasible. As a result, outsourcing such activities to Accelagen can reduce the financial and resource burden, while delivering regulatory submissions in a ready to submit format.