Regulatory Affairs

With our internal regulatory affairs consultant, we streamline product development where standards and regulations exist. The journey from concept to market access will be more efficient, cost effective and risk reduced. Understanding regulatory requirements early is essential for a clear and planned business strategy. During research and design phases, regulatory affairs works closely with our industrial design and engineering teams to align the design process with identified
regulations and standards. We support clients through verification testing including discussions with test houses and overseeing compliance evidence. A key milestone, we have experience in global regulatory submissions. Longer term we can assist with design changes and subsequent regulatory approvals. Regulatory affairs services are available at any stage of a product life cycle. The regulatory pathway can be made easier with the right collaboration along the way.

Meet the key member of our team

Rachael, Regulatory Affairs

Rachael has spent the last decade in the life science industry and specialises in regulatory affairs, particularly in medical devices in the biomedical sector. She has extensive experience creating regulatory strategies for product development lifecycles.
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We strive to find new, better, and more efficient design solutions.

Contact us to discover how we can help to solve your current design challenges and take your product to the next level.

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