Regulatory Intelligence Solutions
Proactive Monitoring of Regulation Changes to Assess the Impact to Your Product Portfolio
Heightened competition and globalization require life sciences companies to extend their global footprint. But with new markets come new regulatory challenges, and the more complex the portfolio, the greater the hurdles that must be overcome. Added to this is the fact that regulatory departments must also stay up-to-date with product lifecycle management and regulatory changes.
Navigating the Global Regulatory Landscape
Celegence helps you navigate increasingly complex and stringent global regulatory intelligence requirements while improving and standardising processes across functions and geographies.
Our global regulatory experts offer insights on regulatory strategy and draw from a local regulatory network to support geo-specific requirements. This global network enables us to deliver up-to-date, robust global regulatory intelligence services to enhance product development and registration strategies.
Robust Database Support for
Global Regulatory Intelligence
To support global regulatory intelligence reporting, Celegence is also developing an international database solution. The objective is to help the life sciences industry monitor global requirements, share information and manage regulatory strategy for a complex product portfolio.
Regulatory Affairs teams will be able to collect, store and share regulatory information based on previous submissions, experience and regulatory monitoring. These valuable insights will assist with future submissions.
Celegence Can Help Your Business with the Following Dedicated Global Regulatory Intelligence Services
- Intelligence on regulatory requirements – including submissions for clinical trials, marketing authorizations, post-marketing maintenance, and understanding global and regional regulatory requirements
- Impact analysis reports – help organizations understand how changing regulations impact the product portfolio
- Reports on current trends – including regulatory operations, interpretation of regulatory information to improve processes and KPIs
Regulatory submission strategy — based on internal data and current/future regulations specific to product types, therapeutic areas and geographical regions
Global and local regulatory submission consulting – to assist companies with defining and monitoring the regulatory submission plan
Storage of ‘soft’ intelligence – to provide a centralized repository for internal and external regulatory intelligence documents
- Performance of competitive gap analysis techniques – to provide regulatory intelligence that supports product benchmarking.
If you’re curious how Celegence can help improve your Regulatory Operations, reach out to us and one of our team members will get in touch with you.