Regulatory Strategy from Day One: Accelagen’s Approach to Accelerating Global Development
Accelagen is helping clients to navigate complex multinational regulatory environments by beginning with the end in mind. Through strategic planning and region specific expertise, Accelagen is helping streamline development, mitigate risks, and accelerate approval timelines.
Navigating complex regulatory requirements across global markets remains one of the greatest challenges in research and development, particularly for emerging biotech and medtech companies. Misjudging the regulatory landscape can lead to increased development costs, significantly delaying timelines, or possibly preventing products from reaching the market altogether. Accelagen’s regulatory affairs team offers an expert solution that combines deep regional knowledge, strategic planning, and a personal, collaborative approach.
Australian CRO Accelagen works with a network of regulatory experts and has numerous established relationships with sites and agencies. The team provides practical guidance tailored to the needs of each project. By focusing on clear communication and thoughtful planning, Accelagen helps ensure the regulatory processes don’t delay clinical progress.
Starting with the Finish Line: Accelagen’s Roadmap for Smarter Regulatory Planning
Accelagen sets itself apart with its strategic approach to regulatory planning, beginning with the end in mind. By working backwards from the final goal, Accelagen helps guide clinical and regulatory decisions early on and identifies potential issues before they can impact timelines or budgets.
Greg Plunkett, CEO of Accelagen, explains, “We start at the end and work backwards. If our clients don’t define where they’re going, then how would they expect to know how to get there.”
The company encourages clients to build regulatory considerations into the design of their product and their clinical studies. “Rather than trying to manipulate information to suit an outcome, it’s better to design quality into a process from the start.” Greg describes. This quality by design approach helps align the data collection with the regulatory approval requirements, and ensures clients have a clear road map from the outset.
Guiding Novel Technologies Through Uncertain Regulatory Terrain
Accelagen helps clients bridge the gap between scientific innovation and regulatory requirements, positioning itself as a CRO able to support development of novel technologies and therapies. With a global network of experts and strong knowledge of scientific trends, the regulatory affairs team helps clients manage regional regulatory requirements even when technology outpaces regulation.
“In some cases, technology is advancing faster than regulations can keep up. Where there’s no precedent, we help develop the pathway.” Greg states.
Regulations constantly evolve as new technologies emerge, and Accelagen helps clients stay current with their extensive experience. As part of the ongoing information sharing, Accelagen helps clients from missing key requirements or relying on outdated strategies, particularly for novel innovations without clear regulatory precedents.
Accelagen Partners with Clients to Build Flexible, Evolving Strategies
Accelagen works with a wide range of clients, from startup biotechs to established pharmaceutical and medtech companies, and support is tailored to each project’s specific needs. Unlike some others in our industry, Accelagen offers customized guidance focusing on client education and agility, and helps clients build strategies that can evolve throughout the lifecycle of their project. “Bigger is not always better. Depth of experience can be the better option.” explains Greg. “We encourage people again just to ask the question and have that initial discussion and then we can see where we can or where we can’t contribute to their development experience”.
Both international and domestic clients receive hands-on support for navigating Australian regulations through Accelagen. By drawing on their network of experts with detailed knowledge of the region’s requirements, Accelagen ensures clients receive region specific support. Their global reach also ensures compliance across markets like the US, Europe, and Asia.
Accelagen believes early engagement with regulators adds so much value to the research journey, as it allows for smoother product development and keeps clients ahead of potential challenges. Companies that delay regulatory consultation often realise too late that their development strategy may be incomplete, which can lead to costly rework and put approvals at risk.
Built for the Long Haul: Accelagen’s Commitment to Informed, Strategic Partnerships
This early engagement also allows Accelagen to identify opportunities that clients may not have considered. Whether it is revising a clinical development strategy or utilizing existing data in a novel way, Accelagen helps clients find new avenues for success.
Accelagen doesn’t want to just deliver regulatory services, they want to empower clients with the knowledge to make informed decisions in the future. The company sees itself as a collaborative partner, not just a hired set of hands. With open communication focused on education surrounding the regulatory process, the regulatory affairs team helps ensure long term client success.