Stop Chasing Regulatory Data Across Information Silos
CSC's regulatory Tracker will seamlessly track and manage your life sciences products as they progress through the global registration process.
As patents expire, regulations increase globally and R&D costs soar, life sciences companies are under intense pressure to simplify their regulatory information management to speed up product approvals.
Needed: Single View of the Truth
Despite the promise of new global submission format and data standards — despite significant investments in document-management systems — many drug makers face a nagging challenge: regulatory compliance information is still stored in spreadsheets and disparate systems, across multiple information silos.
Your regulatory team may spend days or weeks tracking down files and data to:
- Respond to a health authority’s request to see specific details about a specific product registration
- Help your regulatory strategists maximize a product’s lifespan by determining in which countries the product is registered — and whether or not it is marketed there — so they may plan additional registrations
- Help your product owners and regulatory affairs managers determine the impact by global region of proposed changes to product registrations
Imagine If You Could…
- Enjoy a "single view of the truth" of all registration information across your global value chain to manage compliance and speed product development
- Respond rapidly and accurately to requests for product registration information
- Quickly analyze “what if” scenarios to help regulatory strategists make highly informed product-growth decisions
Solution: Regulatory Tracker
CSC's Regulatory Tracker is a powerful software solution that offers a central, Web-based data repository for global product registration information — allowing you to flexibly manage your information in a centralized, decentralized or hybrid model and to simplify data entry for new registration information.
Through Regulatory Tracker, you can quickly and thoroughly manage and track the status of every product in your company’s global life science portfolio. This intelligent database simplifies the management and decision processes for:
- Worldwide product registrations and marketing status
- Marketed product variations/changes through health authority approval and implementation, such as the name change of a manufacturing site
- Regulatory authority correspondence, and post-market commitments and requirements such as pediatric studies, Phase IV studies, and more
- Routine maintenance submissions, such as annual compliance reports, periodic safety updates and renewals