Selecting a highly qualified regulatory partner is of the utmost importance in clearing the path for your newly developed diagnostic. Whether you are in the pre-or post-submission phase, Innak Diagnostics is highly experienced to help you navigate intricate regulatory requirements. We can help you remove obstacles, prepare all necessary documents and consult you every step of the way. Ensure regulatory compliance with Innak Diagnostics as your expert of choice.
What we offer
Developing regulatory strategy.
Compliance Assurance Process implementation.
Generate complete documents for FDA and Health Canada submission.
Support IRB submission of clinical study protocols.