Regulatory Strategy Consulting
Finding the key for regulatory success.
From the regulatory strategy on the early product development to the marketing authorisation applications and post-marketing authorisation procedures, we ensure you the necessary guidance for regulatory compliance.
Whether you need a full regulatory service for a medicinal product or a unique regulatory advice for a medical device, Eurotrials can support you on the regulatory activities throughout the product life cycle.
Our Regulatory Affairs unit provides regulatory strategy support guided by regulatory sciences, essential on today´s product development, and solutions on registration process in our main regions, Europe and Latin America.
Our highly experienced local teams are committed to delivering reliable solutions in line with local regulations, giving you the necessary guidance and support on registration procedures and post-approval activities.
Focused on your target, we provide unique regulatory intelligence and strategic insight, working with the highest quality standards, efficiency and reliability. Moreover, CTI has a history of more than 100 drug and device approvals. Its’ team of multidisciplinary drug and device development professionals rely on past drug development experience, previous interactions with regulatory authorities (including IND preparation and FDA interaction), tenure serving on regulatory committees as reviewers, and current data in the public domain to support our sponsors’ programs.