About Us

We are a London-based pharma and biotech consultancy dedicated to providing expert strategic and technical guidance to clients facing the complexities of global regulatory pathways. With an in-depth understanding of the evolving regulatory landscape, we specialize in helping organisations navigate the multifaceted challenges that arise as they scale their pharmaceutical development internationally.

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Experts specialising in global regulatory affairs

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In today’s interconnected world, sponsors must address a growing array of regulatory requirements across diverse jurisdictions. Our team of experienced professionals offers a unique combination of technical expertise and strategic insight, helping clients not only meet regulatory requirements, but also optimise their development plans to address unmet medical needs. We work closely with organisations to identify potential regulatory hurdles early, develop tailored strategies to mitigate risks, and ensure that global development plans are fully aligned with the requirements of  local jurisdictions.

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Experienced in international markets

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Whether you are initiating a clinical trial in a new region, expanding existing clinical operations, preparing for marketing authorisation, or managing amendments and variations in various jurisdictions, we provide the guidance you need to turn challenges into opportunities. From translational science to clinical development, manufacturing, and marketing applications, we offer end-to-end regulatory expertise to guide pharma and biotech development.