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From strategy, implementation to maintenance, we offer a multi-disciplinary regulatory service to expedite your product development and to streamline regulatory process
Early-stage Clinical Development
I wanted to thank you for all you have done over the past 2 years on the … (product) project. Your strategic insight, practical recommendations and the patience with the crazy questions we often asked you, have been instrumental in the successful approval of … (product) across Europe and the access markets.
Biotech in the US
CEO
Why we trust our expertise
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Ex-agency experience with medical science knowledge
Powered by a team with extensive FDA, EMA and national Regulatory Agency experience, including former regulators, we advises life sciences companies to develop effective strategies to bring innovative technologies from early phase through to post-market compliance.
Global in-house multi-disciplinary expert team
We have a team of regulatory, nonclinical, clinical, market access around the world, collaborating internally and seamlessly to ensure all aspects of regulatory requirements are expertly managed.
Proven experience in innovative medicinal products
We have proven experience in navigating complex regulatory landscape for innovative medicinal products such as cell & gene therapeutic products, combination products, digital health products and microbiome-based products.