For biotech, pharma, and life sciences start-ups, preparing a marketing application can be a daunting, resource-intensive process. However, there are several critical tasks that are essential for submission readiness, but which can also drain your internal team’s valuable time and focus. That’s where the Sugar Water Operations Team comes in — and it's where some of our clients have found us most useful.
Marketing Application Tasks for Outsourcing
One of our specialties is helping start-ups with shorter-term projects to set the stage for a smooth marketing application submission. Here are some of the key tasks we manage to keep your application on track:
1. Document Editing and QC
Accurate documentation is the foundation of any successful marketing application. Our team ensures that all documents are thoroughly edited and quality-checked, eliminating inconsistencies, formatting errors, and other issues that could delay your submission.
2. Pre-Publishing / Submission Readiness
Getting your documents ready for submission involves more than just writing them. We help ensure all of your submission documents are compliant with regulatory guidelines, including carrying out tasks like bookmarking, hyperlinking, setting document properties, and saving your files with the correct PDF settings to ensure all your files pass technical validation.
3. Organizing Correspondence and Essential Documents
A well-organized application package is crucial. We manage and categorize correspondence, regulatory archives and essential documents to ensure nothing falls through the cracks. This step is vital for maintaining clear communication and supporting documentation throughout the regulatory review process.
4. Commitment Tracking
Regulatory submissions often come with post-submission commitments, and tracking those can be challenging. We provide commitment tracking services, helping you stay on top of deadlines and obligations to regulatory agencies.
5. Building BIMO Databases
Creating accurate and comprehensive Bioresearch Monitoring (BIMO) databases is a specialized task that’s critical for FDA inspections. We help you build out your BIMO databases and develop and/or align the related regulatory marketing application components to ensure compliance and readiness for submission and inspection.
6. TMF Reconciliation
The Trial Master File (TMF) is a cornerstone of any clinical submission. We assist with TMF reconciliation, making sure all necessary documents are accounted for and correctly filed and aligned across multiple sites, systems, or solutions, thus mitigating risks of delays or issues during regulatory review.
7. Managing Due Diligence Electronic Environments
Due diligence is a key part of the preparation process, especially if your company is pursuing partnerships or funding. We help organize and manage due diligence electronic environments, so that all parties have secure access to the necessary documents, reducing the time spent preparing for audits and inspections.
Let SWOT Handle Your Marketing Application Tasks and all the Process Entails
Preparing for a marketing application involves a host of meticulous tasks that can pull your team away from core activities. The Sugar Water Operations Team is here to take on these responsibilities, ensuring your start-up is fully prepared for a successful submission. By letting us handle these time-consuming tasks, you can focus on the science and innovation that drive your company forward.