Data and documents to be submitted to several Health Authorities are constantly changing and increasing in frequency, volume and, complexity. New regulations and guidelines demand Life Sciences companies to constantly look at ways of providing the required information to Health Authorities in order to be compliant.
In many cases, existing software and systems might not be able to keep pace with the ongoing Information requested or required by Health authorities. It typically takes more time for a software (3rd party or internally built) system to be able to provide the required information.
Freyr has a dedicated team providing cost-effective, Regulatory Data Management solutions (A creative combination of agile software tools and regulatory resources) that can be an interim or even a long-term approach for solving time-sensitive Regulatory Information Management & Regulatory Reporting needs
- Data Cleansing / Data entry in 3rd party Regulatory & Compliance software and other Custom- software of Bio-Pharma companies
- Design & Development of quick, agile & validated, software tools and accelerators that interface with multiple systems to provide required information
- Regulatory Data Management services, with well-defined SOPs and audit-trail
- Custom Report design and development for Compliance needs
- Building software-based integration kits between R & D / Regulatory / Quality / Safety and other systems – Enabling systems to Interact with each other and handle data-flow between systems
- Regulatory Data Quality checks
- Adding Metadata to Regulatory Documents and Regulatory DMS
- Meeting short IT CSV -Validation timelines, especially for the information required is from GxP systems
- Scheduled Software Vendor product release aligned with Pharma company’s submission deadlines
- Managing data that is not supported by existing systems and is available in silos (Mail boxes, local disks, other intranet locations)
- Setting-up strategies to reduce artwork changes globally
- Provide reports and information where data does not interact properly with different systems and needs to be combined from multiple systems
High Quality Assured For 98% of Data, Successfully Audited By FDAFreyr established Process Automation for client handling large volumes of data and reducing dependency on humans for Quality Assurance.
Freyr rDMS is an end-to-end electronic Regulatory Document Management solution exclusively designed to enable Regulatory Groups and Departments within a life sciences organization to seamlessly create, capture, manage, organize, connect, deliver and archive regulatory data and documents in a compliant, efficient and intuitive manner.
Click on below tab to know more about Freyr’s Regulatory Document Submission and Tracking Solutions