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Drug Master File Document Production Software
6 software items found
by:FreeThink Technologies Inc. based inMontvale, NEW JERSEY (USA)
The ASAPprime software is the only commercially-available software that enables pharmaceutical scientists to quickly and accurately determine drug substance and drug product shelf-life based on the Accelerated Stability Assessment Program (ASAP). This state-of-the-art, statistical software allows prediction of small-molecule drug product use periods, shelf-lives and drug substance retest periods ...
by:Celegence LLC based inDowners Grove, ILLINOIS (USA)
Dossplorer™, our advanced cloud-based dossier management solution eliminates manual steps in the exchange of regulatory dossiers and allows you to share, view and review eCTD, NeeS and other dossier formats from any region and access them in any location! Dossplorer™ allows you to share, view and review eCTD, NeeS and other dossier formats from any region and access them from any ...
by:N-SIDE based inLouvain-La-Neuve, BELGIUM
End-to-end clinical trial supply chain visibility and optimization. Enable ambitious clinical plans through an optimal supply ...
by:MasterControl, Inc based inSalt Lake City, UTAH (USA)
OOS Software to Automate Out of Specification (OOS) Processes to Comply with FDA CGMPs and 21 CFR Part 211 and Part 820 Regulations. In the FDA environment, specifications are essential in maintaining quality. CGMP regulations for finished pharmaceuticals (21 CFR Parts 210-211) and medical devices (21 CFR Part 820) require strict conformance to approved specifications which can be acheived easily ...
by:N-SIDE based inLouvain-La-Neuve, BELGIUM
Optimize end-to-end production planning from DS to IMP. The N-SIDE Production App gives you unprecedented flexibility to optimize manufacturing for your clinical projects, from drug substance (DS) to drug product (DP) to investigational medicinal product (IMP). Use the Production App to build and maintain an optimal clinical production plan that accounts for your specific constraints. Respond ...
by:ConsortiEX Inc. based inMilwaukee, WISCONSIN (USA)
The Assure-Trak Compounding Management System ensures patient safety and compliance while driving efficiencies. For the first time, a single system can be deployed covering all compounding across an enterprise. Users can easily produce both sterile and non-sterile compounds through a single platform. The Assure-Trak® Compounding Management System is designed to fulfill the needs of a single ...