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:
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.
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)
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:
Store all of your documents from Patent Challenge to product, QC methods, Production methods, and Compliance & Quality Management on a single platform
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.
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.
105 College Road East
Princeton, New Jersey 08540
105 College Road East
Princeton, New Jersey 08540
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.
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