PROMETRIKA’s depth of experience makes us uniquely positioned to provide strategic consultation for our partners who are looking to move from the pre-clinical to the clinical stage.

Our Regulatory Affairs experts have over 40 years of diverse experience focusing on regulatory strategy, IND/NDA/BLA/MAA preparation as well as health authority interactions. Engage with our experts to provide support for your IND/CTA enabling and planning activities.

PROMETRIKA has successfully planned and executed global phase 1-3 clinical studies in every major therapeutic area. Members of the PROMETRIKA team have collectively managed thousands of studies in drugs, biologics, and devices with outstanding strategic insight and perspective.

The PROMETRIKA team includes statisticians, medical writers and other clinical research professionals whose combined experience has successfully developed more than 20 NDA/BLA/MAA dossiers for FDA and EMA regulatory submissions.

PROMETRIKA’s comprehensive phase 4 services help our sponsors design and manage real-world evidence trials, build produce awareness, investigate new indications, and fulfill post-marketing regulatory commitments.