Clinplex
Compliance Intelligence for Modern Life Sciences
Clinplex is an AI-powered compliance intelligence platform that connects to your existing QMS and data systems to surface regulatory gaps, strengthen CMC, and accelerate market entry. It’s built for emerging biotechs, commercial manufacturers, CDMOs, and device companies that want fewer surprises from regulators.
An Intelligence Layer on Top of Your QMS
Clinplex connects to your QMS, LIMS, ERP, and document repositories via secure APIs and continuously reviews your quality and CMC landscape against FDA, ICH, ISO, EMA, MHRA, and other global frameworks.
The Platform:
Classifies documents (SOPs, batch records, validation reports, change controls, submission sections)
Checks them against explicit, checkable regulatory and best-practice criteria
Scores issues by risk and impact
Recommends specific remediations with citations and suggested language
Tracks actions and outcomes with a full audit trail