validating the Preqlinic solution

oVERVIEW

INTRODUCTION

PreQlinic™ is undergoing controlled validation with biotech stakeholders – founders, development teams and investors – to ensure the platform is compliant, secure and reflects emerging regulatory expectations for the use of AI in drug development. We follow the guidelines articulated recently by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

wHAT YOU GET THROUGH THIS

Join the validation programme by requesting a sample PreQlinic™ planning report using the form below. We will then contact you to discuss your programme and confirm suitability for participation.

Participants will receive a customised preclinical programme structured around explicit regulatory expectations, assumptions, and risk consideration, covering development pathways, timelines, costs, risks, dependencies and jurisdiction-aware regulatory considerations. This includes structured planning across safety and toxicology, CMC and formulation, incorporation of relevant new alternative methodologies (NAMs) and identification of potential translational biomarkers, presented in an investor – and regulator – ready format.

What we request in return

In return, we kindly seek structured feedback to help us refine outputs during this validation phase and further develop our solution to meet the needs of biotechs.

JOINING THE VALIDATION PROGRAMME

Please complete all sections of this form and we will send you a a sample report within a few hours.

Alternatively, feel free to message us directly on info@preqlinic.com.