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Regulatory Operations: secure your clinical submissions

Keena Life Sciences supports sponsors in their clinical regulatory operations, from application preparation to final filing. Medicinal products and medical devices fall under distinct regulatory frameworks, and we adapt our approach to each type of project.

Medicinal Products

EU CTR (Regulation 536/2014) / CTIS

For medicinal product clinical trials in the European Union, our support operates within the Clinical Trials Regulation framework and the CTIS portal.

check_circlePreparation of the Clinical Trial Application (CTA): Part I and Part II
check_circleSubmission and follow-up via the CTIS portal
check_circleResponses to Requests for Information (RFIs)
check_circleManagement of substantial modifications
check_circleExtension to additional Member States
check_circleRegulatory notifications and end-of-trial management
Medical Devices

MDR / IVDR

For medical device clinical investigations, our support follows the requirements of Regulation (EU) 2017/745 (MDR) and, where applicable, Regulation (EU) 2017/746 (IVDR).

check_circlePreparation of applicable MDR clinical investigations
check_circlePost-Market Clinical Follow-up (PMCF)
check_circleSet-up and follow-up of registries
check_circleMedical device-specific monitoring
check_circleDevice accountability and traceability
check_circleRegulatory coordination with notified bodies and competent authorities

Expert navigation of regulatory frameworks

Our clinical operations follow a controlled quality framework, aligned with applicable requirements, sponsor procedures, and ICH E6(R3) Good Clinical Practice principles. Our team monitors these evolving frameworks to anticipate the points of attention specific to your protocol.

This ongoing watch limits back-and-forth with relevant authorities and reduces the time needed to obtain trial authorization or clinical investigation approval.

It also covers changes to the European framework as well as to countries where your study runs in parallel. We flag any change likely to affect your filing timeline to your team.

A file built in collaboration with your teams

We work in direct collaboration with your medical and regulatory teams, rather than in full autonomy. This approach ensures the file faithfully reflects the sponsor's protocol and scientific choices.

Each step of building the file is jointly validated before submission, limiting the risk of a follow-up request from the authorities.

To secure your next submission, contact us now to assess your file arrow_forward

When should you seek support for regulatory operations?

This support is useful when your internal team lacks the availability ahead of a multi-country filing deadline. It's also useful when facing a substantial modification or an extension to new Member States.

A well-prepared submission reduces the risk of delay at study or clinical investigation start-up. Our team structures each file to limit iterative exchanges with relevant authorities.

We also step in as ad hoc support when your internal regulatory team faces a peak of filings across several countries, which can sometimes exceed its processing capacity within the deadlines.

Preparing a CTIS submission, a substantial modification, or a medical device clinical investigation?

Let's talk about your regulatory needs.

Get in touch