Pharmaceutical corporations face challenges distinctly unique in formulated products manufacturers. They face continually changing healthcare legislations, disparate R&D facilities, complex drug portfolios, and increasing competition in nearly every market.
Selerant equips pharmaceutical companies to collaborate more effectively, ensure traceability, ensure compliance, generate documentation, and expedite products to market.
Raise compliance and safety by increasing visibility, traceability, and audit logs.
“85% of surveyed Selerant customers have seen a 41-60% or higher improvement in traceability since using DevEX.”
- Easily generate Structured Drug/Product Development Record (ePDR)
- Integrate New Product Development based on Quality by Design (QbD) principles
- Ensure compliance and proprietary knowledge with Global Product Registration of E Common Technical Documents (eCTD)
- Leverage knowledge base
- Ensure compliance with ICH Q8-Q10 applicable over entire product lifecycle
- Easily generate eCTD for filing
- Elevate visibility with molecule hierarchy (and all materials used in a molecule)
- Define roles and responsibilities for Qbd-based PDR
- Leverage Common Technical Documents (CTD)