How Accelagen is Navigating Regulatory Lifecycle Management
Clinical product development continues beyond initial market approval, with ongoing regulatory oversight playing a critical role throughout a product’s lifecycle. At Accelagen, clinical research expertise and in-depth knowledge of regulatory lifecycle management in the Australian and New Zealand market is providing international clients with the support they need to stay compliant and maintain market access.
Australian based leading CRO Accelagen is known for its agile, client focused services across clinical trials, data management, and regulatory procedures. With excellent knowledge of regulatory requirements in the region and a strong network of partners, Accelagen supports both local and international clients developing clinical products in Australia and New Zealand.
What Makes Accelagen Different?
The consulting environment at Accelagen, where a variety of contracts, team culture, and opportunities to contribute to clinical and post-market projects is what attracted Sneha Antarvedipalem to join their regulatory affairs team. Her current focus is on lifecycle management; the regulatory maintenance of products already registered in Australia and New Zealand.
This includes submitting variations for changes to product manufacturing, such as formulation, or safety updates, as well as ensuring that documentation remains up to date and in line with new clinical findings. Sneha supports regulatory maintenance from the smallest to the largest modifications.
“With Lifecycle Management specifically it is a lot of post market product maintenance for us… whether that’s regarding labeling updates or chemical, manufacturing and controls changes” explains Sneha. “…from the smallest editorial artwork updates to the largest tech transfer for GMP, we have to actually review those medicine dossiers, update every relevant document, and provide regulatory strategies for submission in both Australia and New Zealand.”
Global Regulatory Lifecycle Management Expertise
For international clients, there is often a market for adapting global dossiers from FDA or EMA to submissions for the TGA in Australia or Medsafe in New Zealand. While there is some regulatory alignment between regions, local expertise is essential, especially first time sponsors, whether they are small start-ups or larger sponsors such as multi-national pharmaceutical companies.
Accelagen recently supported a client from the APAC region submitting to the TGA in Australia. The process involved adapting the client’s local submission to meet Australian standards and effectively communicating the differences between the two regulatory systems, which required significant hands-on collaboration and discussion to reach a successful outcome.
Accelagen’s clients range from large pharmaceutical companies to small start-up biotechs. Some clients only need local regulatory representation, while others rely on the team for the full suite of regulatory planning and execution. The team provides guidance on everything from safety reporting and label exemptions to managing changes in manufacturing sites and major variations such as adding additional clinical indications to registered medicines.
Strong working relationships with regulatory authorities are an important part of Accelagen’s strategy. Sneha emphasises the value of understanding how different agencies operate and adapting accordingly. This helps streamline submissions, address feedback effectively, and avoid delays caused by misunderstood procedures.
For many clients, Accelagen’s local presence is a major advantage. The team is able to respond quickly to changing regulatory requirements and support clients in identifying gaps in their documentation or compliance.
Sneha explains that “…recent changes to Australia’s medical device regulations have introduced new classification and data management rules which may have been a surprise to many international clients.” Accelagen has been supporting clients through these updates, helping sponsors adjust their submissions to remain compliant and avoid delays.
Regulatory Support for Clinical Development and Post-market Stages
Another of Accelagen’s strengths is its ability to provide regulatory support across both clinical development and post-market stages. This allows clients to work with a single, agile team from early planning, through trials, and on to lifecycle maintenance. Internal collaboration across regulatory, clinical, and product safety teams means that information flows smoothly and efficiently throughout the company.
Accelagen’s regulatory team offers personalised, strategic support grounded in excellent local knowledge and cross functional expertise. As more companies look to expand into the Antipodean markets, having an experienced, hands-on regulatory partner like Accelagen can make all the difference in bringing safe and effective therapies to patients.