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Xybion for
Generics, Specialty & OTC Drugs

Your Single Digital Platform for Generics & Specialty Pharma R&D, Quality, Compliance, Laboratory, and Manufacturing Operations

Today’s Generics and Specialty Pharmaceutical companies are highly competitive in a crowded marketplace with the same strict regulatory scrutiny and enforcement as larger pharmaceutical organizations. However, Generics and Specialty Pharma companies are forced to meet these standards with fewer resources and tighter margins than “Big Pharma.”

To be successful and thrive under these conditions, management needs to have a sharp focus on:

  • Reducing ramp-up time, reduced errors & deviations, and improve quality.
  • Improving efficiencies and cost savings
  • Optimizing operations – higher throughput with existing resources
  • Reducing Audits, FDA inspections, and 483 Risks

Xybion’s Generics and Specialty Pharma XD (GSP-XD) digital cloud-based platform is uniquely developed to satisfy the demands of Generics and Specialty Pharmaceutical organizations.

Key Distinctive Features

  • Pre-configured workflows and audit-ready reporting that reduces audit risk.
  • Compliance Risk Predictor allow for understanding 483 patterns and manage internal SOPs and processes to be always ready to successfully meet the FDA inspection requirements.
  • Data Integrity ensures that data is complete, consistent, and accurate.

You can continue to manage your critical quality assurance, compliance, and R&D operations with paper-based or legacy technologies, but no combination of these solutions will allow your organization to scale and reach critical mass efficiently and cost-effectively. Xybion’s GSP-XD platform can help you achieve step changes in your company’s performance and improve your Return-On-Investments (ROI)

Out-of-the-Box Functionality

With its pre-configured workflows and ready-to-deploy functionality, GSP-XD provides you with the digital platform and tools to effectively manage your daily operations:

Formulation Management

Predictive Compliance

Stability Study Management

Corrective and Preventative Actions (CAPA)

Document Management

Store all of your documents from Patent Challenge to product, QC methods, Production methods, and Compliance & Quality Management on a single platform

Audit Management

Complaint Handling

Validation Management

Employee Training and Competency

This cloud-based solution allows customers to deploy the solution rapidly and adapt to existing requirements without the complexities of configuration and ongoing maintenance.  However, GSP-XD is built on Xybion’s highly configurable, low code technology stack which facilitates “configurations” vs. “customizations.” In layman’s terms, this simply means that we can deliver client-specific workflows and processes in DAYS as opposed to MONTHS with older legacy-based applications. This also means that our clients are provided a high level of control allowing them to change and configure their instance WITHOUT affecting core code, hence no need to re-validate.

Meeting Your Needs Today and in the Future

In addition to being out-of-the-box ready, GSP-XD is a modular platform, meaning that additional functionality or modules can be deployed rapidly without disrupting existing business operations and ensuring business continuity. This modular approach allows you to commit to and deploy ONLY the functionality that you need TODAY and remain positioned to scale and ramp up rapidly new functionality as needed. GSP-XD provides One Platform and One Solution to meet your digital workplace demands wherever you are in your manufacturing journey.

Learn more about Xybion for:

Pharmaceuticals

Medical Devices

Government

Biotech

OTC, Specialties and Generic

Healthcare

Book a Demo

Book a demo with us now to experience a tailored solution that specifically addresses your current business needs.

Reduce Compliance Risk

Implement an all-in-one digital cloud platform to be always ready to meet compliance needs.

Increase Efficiency​

Replace standalone applications and paper trails with fully customized digital solutions.

Reduce Cost by 30%

Compliance Embedded, Quality Engrained, Data Integrity Assured

Audit Management

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Princeton, New Jersey 08540

Phone

+1-609-512-5790

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All Rights Reserved.

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All Rights Reserved.