Regulatory Affairs

Regulatory Development Strategy

March 8, 2017
Early preparation of a regulatory strategy is important to an effective development program. To define a projects objectives and outcomes provides a goal that all team members can focus on.  Without understanding the regulatory pathway can result in studies being undertaken that are not critical to a products success. Accelagen get involved in the development

Regulatory Submissions

March 7, 2017
Accelagen have prepared and submitted a large variety of regulatory applications, including: New chemical or biological medicines Generic applications Device/IVD Inclusion Applications Orphan Drug Designations (ODDs) Investigational New Drug (IND) applications Investigational Device Exemption (IDE) applications Quality or Clinical variations Self-assessable notifications Annual Reports Clinical Trial Notifications Accelagen have developed various templates to prepared documents

Gap Analysis

March 6, 2017
The pathway required to bring a new therapeutic product to realization can be complex. With subtle changes early the development program having a negative impact. A thorough and critical analysis of the regulatory strategy and intended pathway can identify any potential gaps and address potential challenges before they occur. Through our experiences in the regulatory

Staff Resourcing

March 5, 2017
Demands on internal resources fluctuate throughout the year, and often increase substantially without notice. During these peak times, you need effective workers quickly. Accelagen has a team of highly experience regulatory and clinical research professionals who can come into an office and commencing work to help alleviate these peak times. Whether it be a small

Submission Publishing

February 3, 2017
With the move towards electronic Common Technical Document (eCTD) format dossier compilation, Accelagen have access to regulatory dossier publishing software capable to deliver electronic dossiers ready for submission in Australia. Europe or to the US FDA. Whether it be a marketing application or quality variation, we have the capabilities to suit your needs.

Australian Sponsor / MAH

February 3, 2017
For many international clients, establishing a formal entity in Australia in order to remain the local Sponsor or Marketing Authorisation Holder (MAH) can be complex and time consuming. And when considering the regulatory and legal requirements imposed on the Sponsor in accordance with local legislation, this decision may become less attractive. To directly address this,

Lifecycle Management

January 3, 2017
Gaining regulatory approval for a new product is a significant, however this may only be the beginning. Developing data to support new claims, new patients or more efficient manufacturing steps require update and modification to the regulatory status and documentation. Accelagen can provide expert support in the strategic management of the regulatory processes, including preparation