Clinical Regulatory Submission: secure your trial authorizations
Keena Life Sciences supports sponsors in their clinical regulatory submission, from application preparation to final filing. We work with ethics committees, ANSM and relevant authorities in France and internationally.
The scope of our clinical regulatory submission service
Our support covers all the steps needed to obtain and maintain your authorizations:
Expert navigation of regulatory frameworks
ICH GCP requirements and national frameworks evolve regularly. Our team monitors these changes 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.
It also covers changes to the French 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_forwardWhen should you seek support for clinical regulatory submission?
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 complex protocol amendment.
Well-prepared clinical regulatory submission reduces the risk of delay at study 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 an ethics committee or ANSM submission?
Our team supports you in building the file.
Get in touch