Product Overview
Pharmacovigilance (PV) is critical to the safety of medicines, ensuring that adverse effects are detected, assessed, and managed to protect public health. However, most PV solutions on the market are designed for large pharmaceutical companies — meaning they are often complex, costly, and inaccessible for smaller businesses.
Developed in collaboration with Regxia, RegDocs365’s PV module offers an affordable and scalable solution tailored specifically for small to mid-sized companies, making it easier than ever to meet post-authorization safety commitments.
Why Choose the PV Module for RegDocs365?
Small companies often struggle with manual processes or patchwork solutions for managing PV, but with this module, those challenges are a thing of the past.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
Key Features Include:
- Streamlined Case Intake: Receive and categorize adverse event reports from various sources, including healthcare professionals, patients, and regulatory authorities. Easily track the report’s status and ensure timely processing.
- Comprehensive Case Management: Process cases easily, send them for adjudication, assess for regulatory reportability, and generate reports in compliance with requirements.
- Signal Detection & Management: Detect and analyze safety signals with confidence, helping you proactively manage risks and ensure your products' safety.
About the company
RegDocs365 came about as a result of the collaboration between Court Square Group hosting a submission processing environment for eSubmissionSolutions. The founders, Keith Parent from Court Square Group and Antoinette Azevedo from eSubmissionSolutions had been working together for a number of years. Recognizing the significance of the environment that Antoinette was using for her client base we decided that this would be a great offering for small to mid-size companies looking to do their own Regulatory filings. By replicating the environment for other Regulatory customers we were able to have our first regulatory offerings featuring the DIA EDM and eTMF reference model.
