PROMAP Clinical is our proprietary document workflow platform. Via a shared cloud-based portal spanning all the partners in the supply chain, it supports the transfer, storage, review and approval of all supply chain documentation including:

      • Manufacturing Site Audit reports
      • Qualified Person Declaration of GMP Compliance
      • Investigational Medicinal Product Dossiers 
      • Clinical Trial Approvals
      • Artwork Specifications and Label-copy
      • Copies of Master and Executed Batch Records
      • Certificates of Analysis / Compliance
      • Shipping Documentation
      • Temperature Data Records

Conscious of the frequent need for urgent shipments to Clinical Sites, the platform is designed to facilitate fast, efficient and safe release of product through a secure, digital environment.

Regulatory Approvals

The system is fully qualified (21 CFR Part 11 and EU GMP Annex 11).