That’s why we help companies of all sizes ensure that their development plans are designed and implemented for regulatory approval and market access.
We enjoy taking on ambitious projects and understanding your product’s challenges is the heart of what we do. Through listening and brainstorming, our experienced and motivated teams will always work to put the best solutions forward.
Contact us for a free consultationOur team is part of the world's most extensive network of professionals, composed of leading industry and academic experts in clinical medicine, biology, and pharmaceutical sciences.
Project design and implementation, risk mitigation, exploiting opportunities, resource allocation, project sustainability, and success evaluation criteria.
Learn moreRegulations and guidelines, market access requirements, regulatory strategy and implementation, evaluation of technical data, and regulatory authorities.
Learn moreHealth economics, reimbursement strategies, key decision makers and stakeholders, market assessment, clinical and economic product benefits.
Learn moreOur goal is to help clients maximize the value and life cycle of their product amid a constantly-evolving regulatory environment. By developing innovative, tailored, and cost-effective strategies, we help our clients achieve milestones and cultivate the path to market access.
Meet our TeamsGet regular, relevant updates on recent developments in regulatory affairs, pharmacovigilance and Digital Health innovation.
Regulation (EU) 2023/607 addresses imminent risks of medical device shortages in the EU by extending transition timelines of Regulation 2017/745 EU (MDR) up to the end of 2027/2028, thereby allowing continues marketing off legacy devices based on previous MDD/AIMDD Certificates.
Learn moreFrom development to market access, we help companies of all sizes ensure that their development plans are designed and implemented to gain regulatory approval and access to market in their chosen countries.
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