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).