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Discovery, Pre-clinical, and Early Development (GLP & Non-GLP)

Developing a new drug from original idea to the launch of a finished product is a complex process which can take upwards of fifteen years and cost in excess of $1 billion. To remain competitive, research centers must find ways to streamline early processes to identify molecules which possess suitable characteristics. Increasingly this means optimizing business processes such as data capture, consolidation, and analytics across the drug discovery process, from initial target identification and validation, through assay development, high throughput screening, hit identification, lead optimization and finally the selection of a candidate molecule for clinical development.

Xybion’s Labwise platform is uniquely positioned, offers comprehensive business process enablement for today’s global laboratory enterprise, resulting in faster cycle times, reduced IT costs, and increased innovation. As a fully configurable, laboratory-centric business process management platform, Labwise enables critical business processes in preclinical and early development, such as (but not limited to):

  • Material Management Workflows
  • Equipment Lifecycle Management
  • Quality and Compliance management
  • Document distribution and approvals, including SOPs, Work Instructions, Assay Development Methods
  • Process Chemistry Methods, and
  • Issue tracking for regulatory submission management purposes, supporting the creation of IND and NDA packages

For pre-clinical laboratories operating in both GLP and non-GLP environments, Xybion offers an end-to-
end solution that begins with data capture, through data consolidation and aggregation, into data analytics and reporting. By leveraging Labwise’s integration with the Pristima® and SavanteTM platforms, Xybion offers an out-of-the-box solution for preclinical study management, data capture, analytics, consolidation, and process compliance enablement.
Learn more about Xybion solutions for discovery, pre-clinical, and early development:

Pharmaceutical Development (New Drug And Generics)

Xybion’s Labwise platform offers out-of-the-box, pre-configured workflows to support Pharmaceutical Development laboratories operating under both GMP and non-GMP conditions. Functions to support and integrate analytical development, method development, chemical development, and formulation development activities promote continuous improvement, operational efficiencies, and reduced costs.

Labwise enables the management of typical material, process, and equipment workflows associated with developing new drug entities and generics, such as:

  • Formulation management
  • Tracking analytical methods
  • API and associated recipe approvals
  • Unit operation process handling and tracking
  • Replacement for equipment paper log books, enabling tracking of calibration schedules, vendor
  • maintenance, and more

Labwise product page 

Pristima product page 

Savante product page

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