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Solutions for Biotechnology Manufacturers

The path from drug and device discovery to its actual delivery to patients is often long and costly, taking on an average of 15 years of research and development and may often require an investment of more than $800 million before Food and Drug Administration (FDA) approval is obtained. In parallel to this process is ramping up for both approved product production and that products associated marketing campaign, with an estimated cost of $1 million in lost revenue for each day of delay in delivering a new medicine to market.

Hand-in-hand with this product development process are the intense business and regulatory compliance demands that must be adhered to in order to mitigate any non-compliance conditions to help ensure the timely release to market for any new product, as well as, existing product lines.

Industry Challenges

A biotechnology company's ultimate goal is to produce a safe, reliable, and effective drug product or device. We at ThinSpring acknowledge that a certain level of reliance is placed on product and service providers that thoroughly understand the technical constraints and requirements of pharmaceutical product and device development and release processes, including the designing, implementing, validating and sustaining of compliant support systems. Included in this challenge is the management of global quality initiatives that drive continual improvements throughout the enterprise.

Solutions

At ThinSpring, we understand that compliance activities do not exist in a vacuum and that they can substantially impact your company’s core business processes. To help your company meet these challenges ThinSpring has developed the fully-web based XML Sage™ Modular Software Application Suite that is deployed from a centralized location and available to members of your company’s multi-national teams. This connectivity helps promote quality throughout the enterprise by allowing the management of multiple initiatives that can be continuously monitor and proactively improve the quality process.

The XML Sage™ Modular Software Application Suite is a XML based software product, developed to provide an information infrastructure that supports both your drive for operational excellence and your need for accurate, timely compliance to agency regulations or business process need. Flexibility and scalability are at the heart of any XML Sage™ Modular Software Application Suite solution, meeting stringent regulatory demands in a secure, role based, password encrypted web-based environment that provides a true enterprise approach to:

Quality Systems and Process Management
Product Lifecycle Management
Tracking and management of costly Auditing and Validation activities
Tracking of Clinical Trail activities, trail approval status, qualified sites and resources
Product Information Labeling and Labeling Submissions Management
Business Continuity Management

Easily configurable, the XML Sage™ Modular Software Application Suite provides business process solutions that are easily modified to incorporate your specific terminology, workflow, and business rules. As the dynamics of your industry changes, you’ll be reassured to know that, when and if you need it, the scalability of the XML Sage™ Modular Software Application Suite will allow you to easily change your solution to meet the continually advancing requirements around the specialized business needs of your operational processes.

Offering a complete collaborative environment, the XML Sage™ Modular Software Application Suite delivers a powerful, interactive knowledge sharing tool that supports open communication on a global level, allowing your multi-national team to exchange ideas, share valuable knowledge and address tasks or activities all assessable through their local browser.