Preparing for a Successful Approval Process and Safety Planning
The first hurdle to overcome is to build the marketing application timeline. We always advise that you start with the submission date and work the timeline backwards. Ensure that you’ve included enough time for publication processes, changes based on agency meetings, and any downstream effects of potential revision requests. And don’t forget post-marketing updates, annual reports, and safety surveillance requirements.
In an ideal world, the timeline would be linear, as illustrated below, but the reality is that many of these items happen in parallel.
Our regulatory, statistical, medical/safety, and communications experts provide real-world experience and knowledge of all the challenges that arise when preparing your marketing application for approval.
We can help:
The Marketing Application Planning Process
Regulatory & Medical Writing
Data and Statistical AnalysisStandardize the clinical trial data into:
Avoid Unknowns with the Right Expertise
We understand that the stakes and pressures are high when you are preparing, submitting, and waiting for approval of your marketing application. The submission process is an overwhelming coordination effort. We have the experience, agility, and scientific-minded experts to help you navigate this process successfully and to monitor your product’s safety for its duration on the market.
In 2020, Veristat teams supported marketing applications for 10% of all FDA Novel Drug Approvals.
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More Marketing Application and Pharmacovigilance Support
Explore some of our specific expertise for marketing application planning:
|Marketing Applications||Data Standardization||Medical Writing||Regulatory Agency Meeting Support|
|Regulatory Publishing||Project Management||Pharmacovigilance and Post-Marketing Safety Surveillance|