OxygenMinds

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

Product Registration

Manage all marketing and investigational registration information including packaging specifics, indications, and manufacturing details
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Authority Interaction

Authority Interaction

Retain and classify all correspondence with health authorities. Create records with tasks and report progress
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02
Change Management

Change Management

Track proposed changes to global registrations. Automate the creation of any planned change triggered by the quality change control process
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Submission Tracking

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

Support the entire lifecycle
05
Dashbords & Reports

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

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

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

Life Cycle Management

Implement dynamic workflows for submission processes, allowing easy participant modifications and streamlined authoring, review, and approval stages.
03
Commitment Progress

Commitment Progress

Generate commitment records with associated tasks and track progress against outstanding commitments and deliverables through reporting
04
collaboration

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

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

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

Validation in Background

Implement automated validation and link testing using a background service that identifies issues as submissions are constructed
02
Submission Ready

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

Real- Time Status

Obtain insights into the entire submission process, including the status of submissions and the readiness of individual documents
04
Gateway Integration

Gateway Integration

Submit through electronic gateways of health authorities, automatically archiving all gateway receipts and responses
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