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From strategy to maintenance, together we execute a multi-disciplinary plan to expedite your product development founded on science and technologies.
Regulatory
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 to markets.
Biotech in the US
CEO
Agency experience with medical science and quality knowledge
Powered by a team with extensive FDA, EMA and national Regulatory Agency experience, including former regulators, we advise 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
An exceptional team of CMC, nonclinical, clinical, patient-focused experts around the world, collaborating seamlessly to generate evidence for regulatory approval and access to market.
Proven experience in innovative medicinal products
Demonstrated experience in navigating complex regulatory and market access landscapes across divers innovative HealthTech products including cell & gene therapies, combination products, digital health solutions, and microbiome-based innovations.
Questions? Get the answers by our expert team
No two product developments are the same, talk to our experts about your development challenges and we will provide your actional recommendations.