We get our hands dirty
In the complex world of pharma marketing, precision and reliability are everything. That's where we come in. We handle the nitty-gritty, ensuring your submissions into Veeva are clean, compliant, and on point—every time.
We don’t chase awards or aim to dazzle with creative flair. Our focus is simple: getting the job done right, the first time, every time. With us, there’s no room for error, no room for ego. Just meticulous execution that keeps your projects moving forward smoothly and without delays.
No Flash, Just Function
Experience the Difference of Getting It Right the First Time
IT COMES NATURAL TO US
A company that specializes in the infrastructure work of submitting creative into Veeva for Medical, Regulatory, and Legal (MRL) reviews would have several core functions centered around ensuring that every submission is accurate, timely, and compliant with industry standards.
The core functions below ensure that the company can reliably manage the intricate and often challenging task of submitting creative content into Veeva, streamlining the process for their clients, and ensuring that all materials are compliant and ready for regulatory review.
Submission Preparation and Formatting
Ensuring that all creative assets, including text, images, and videos, are properly formatted and compliant with the specific requirements of Veeva and the eCTD submission process.
This involves converting files into the required formats, labeling assets correctly, and ensuring that metadata is accurately applied. The goal is to prepare content that meets all technical and regulatory criteria before submission.
Submission Execution
Managing the actual submission of creative assets into Veeva for Medical, Legal, and Regulatory review process
This involves uploading content into the Veeva Vault, ensuring that all files are correctly linked, tagged, and routed to the appropriate stakeholders for review. The company will flag any reference or annotation issues in advance so they can be addressed before the final submission deadline. The company would handle all aspects of the submission process, ensuring that everything is done efficiently and without error.
Review Coordination and Follow-Up
Assuring comments are seen and addressed by appropriate agency and client stakeholders.
This includes monitoring the review process, an accompying grid of responses and sharing with appropriate partners, and flagging when there are issues so the subject matter experts can address. The company would also track the progress of each submission, providing updates to clients and ensuring that deadlines are met.
Version Control and Documentation
Maintaining meticulous records of all submissions, versions, and approvals within Veeva.
The company would ensure that every change, comment, and approval is properly documented and versioned after the initial submission. This helps in maintaining a clear audit trail, which is crucial for compliance and future reference.
Training and Support
Providing training and support to agency submission teams and stakeholders on the Veeva submission process.
This includes educating teams on best practices for submission, troubleshooting common issues, and offering ongoing support to ensure that everyone involved in the process understands how to work within Veeva efficiently.
Quality Assurance and Continuous Improvement
Implementing quality control measures and continuously refining processes to improve submission accuracy and efficiency.
The company would regularly review its submission processes, identify areas for improvement, and implement changes to enhance performance. This may involve updating standard operating procedures (SOPs), adopting new tools, or refining workflows.