Veeva Regulatory
Empowering Regulatory Excellence in Pharma: Streamlined Compliance with Veeva Solutions
Unlocking Regulatory Excellence with OxygenMinds- Your Veeva Partner
At OxygenMinds, we’re your dedicated partners in navigating the complex landscape of regulatory affairs with our specialized Veeva Regulatory IT services. Here’s a quick overview of what makes us the go-to choice for unlocking regulatory excellence
Vault Registration
Product Registration
Manage all marketing and investigational registration information including packaging specifics, indications, and manufacturing details
01
Authority Interaction
Retain and classify all correspondence with health authorities. Create records with tasks and report progress
02
Change Management
Track proposed changes to global registrations. Automate the creation of any planned change triggered by the quality change control process
03
Submission Tracking
Build a submission outline and automatically match documents to the outline. Build and publish clinical and non-clinical reports using Report Level Content Plans.
04
Support
Support the entire lifecycle
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Dashbords & Reports
Create easy, self-serve reports showing information with any combination of attributes. Address any bottlenecks or delays by tasks assignments in real time
06
Vault Submission
Reference Model
Ensure content taxonomy aligns with industry standards like eCTD and DIA EDM reference models, allowing for customization to meet specific business needs
01
Real-time Submission
Auto-generate TOCs for regulatory submissions, include planned content, and provide real-time submission status reporting. Facilitate global content plan reuse
02
Life Cycle Management
Implement dynamic workflows for submission processes, allowing easy participant modifications and streamlined authoring, review, and approval stages.
03
Commitment Progress
Generate commitment records with associated tasks and track progress against outstanding commitments and deliverables through reporting
04
collaboration
Authorize users securely through a unified cloud location, eliminating the need for external users to enter the corporate firewall, receive laptops, or acquire network IDs.
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Reports
Compile and publish reports like clinical studies and safety reports. Include independent hyperlinks for early use in the document review process
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Publishing
Auto-Match Submission
Automate processes by employing rule-based auto-matching, utilizing documents and metadata from submission content plans to eliminate manual steps
01
Validation in Background
Implement automated validation and link testing using a background service that identifies issues as submissions are constructed
02
Submission Ready
Automatically format all documents according to PDF standards and enable direct navigation of web links, cross-references, and tables of contents from the viewer
03
Real- Time Status
Obtain insights into the entire submission process, including the status of submissions and the readiness of individual documents
04
Gateway Integration
Submit through electronic gateways of health authorities, automatically archiving all gateway receipts and responses
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