With our internal regulatory affairs team, we streamline product development where standards and regulations exist. i4PD's regulatory design services ensure that 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. Our regulatory design services include supporting clients through verification testing, engaging in 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.

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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