drug production software
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Stability - ASAPprime
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 ...
By FreeThink Technologies Inc. based in Montvale, NEW JERSEY (USA).
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N-SIDE Suite - Game-Changing SaaS Platform
The N-SIDE Suite is a game-changing SaaS platform supported by a team of industry-leading experts. ...
By N-SIDE based in Louvain-La-Neuve, BELGIUM.
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Phoenix - Version WinNonlin - Industry Standard for Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Software
the US FDA, Japan Pharmaceutical and Medical Device Agency (PMDA), China Food and Drug Administration (CFDA), and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), all use Phoenix WinNonlin to evaluate drug ...
By Certara based in Princeton, NEW JERSEY (USA). from Phoenix PK/PD Software Software line
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Freyr SPL-SPM - Structured Product Labeling/Monograph (SPL-SPM) Software
Structured Product Labeling (SPL) & Structure Product Monogram (SPM) is the mandatory document markup standard for Regulatory submission of label content, product and facility information, and any subsequent changes to an existing label information in an electronic format. SPL-SPM format defines the ...
By Freyr Solutions based in Princeton, NEW JERSEY (USA).
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Disease-specific Clinical Omics Datasets Software
Robust, disease-specific datasets powered for statistical significance with whole genome data and detailed longitudinal clinical ...
By Genuity Science based in Boston, MASSACHUSETTS (USA).
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OOS Software - Out of Specification Software
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 MasterControl, Inc based in Salt Lake City, UTAH (USA).
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DRIVE - Next-Gen Clinical Supplies & Logistics Platform
An enterprise-level clinical supplies management technology; Developed, supported, and maintained by customer-obsessed endpoint professionals; Inspired by client needs for supplies management in IRT & non-IRT studies; Makes complex tasks (e.g., drug pooling, reconciliation) simple; Improves product ...
By endpoint Clinical based in Wakefield, MASSACHUSETTS (USA).
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