Pharmaceutical and biotech companies strive to deliver the best medicines and therapies to their patients, but are faced with numerous industry challenges including increasing competition, globalization, lower margins and patent expiration. Additionally, these companies also face a greater frequency of regulatory authority interaction and therapeutic innovation, particularly those focused on small target populations.
Consequently, pharmaceutical and biotech organizations often struggle to manage and maintain documentation throughout the development lifecycle. Functional areas such as Quality Assurance, R&D and Regulatory often create and manage their own silos of content that cannot be effectively synchronized. This is especially true when disparate systems are unable to talk to each other.
Pharmaceutical and biotech companies often face unforeseen risks that can reduce the effectiveness and compliance of their systems – especially when facing the challenges of controlling changes across multiple sites in a global enterprise.
Finally, regulatory requirements can challenge the most dedicated and process-driven organizations. With numerous regulatory areas to focus on, and frequent regulation change without notice, problems arise. Without effective management, regulatory hurdles can quickly clog the new product pipeline.
An Online Quality and Compliance Platform
Pharmaceutical and biotech companies need an effective way to adapt and manage their processes to meet these pressing industry challenges. Dassault Systèmes License to Cure for BioPharma solution has been designed to help companies be more reactive and responsive to market needs while providing an effective governance model.
Disparate silos of information can be united into one online platform, helping companies digitally share their quality, compliance, and regulatory activities across their global operations. License to Cure helps businesses transition from outdated practices to a connected and transformative environment where companies can collaborate with their supply chain partners and regulatory agencies, both pre- and post-market. This transparency between early clinical activity, through manufacturing, and on to full commercialization is essential to success.
As a web-enabled solution, user interfaces provide easy viewing, access and printing of controlled documents across organizations. Full life cycle management of controlled documents reduces time to search and collect information, and automatically provides an audit trail for full traceability. This interface enables simultaneous collaboration by multiple authors and reviewers, and streamlines the approval process.
Data can be captured, reviewed, processed and approved through an interface that works as a single point of access to compliance content. This helps pharma and biotech companies to integrate their Quality Management Systems (QMS) across their global operations. With secure, audited data sharing, users can access documents and data from anywhere, allowing them to adhere to quality processes and minimize duplication of information.
Designed for the highly-regulated life sciences environment, License to Cure for BioPharma provides end-to-end document and workflow management in alignment with regulatory guidelines. This serves to reduce costs, improve efficiencies and accelerate submission of applications to the appropriate regulatory bodies.
License to Cure for BioPharma provides seamless and continuous data flow to accelerate innovation, enabling enterprise organizations to improve yields, reduce the number of issues and minimize recall occurrence, thereby improving both product quality and quality processes needed to reduce risk.
With an integrated, end-to-end solution, businesses can transform the way they bring innovative therapeutic solutions to patients. To find out more, download the solution brief.