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.

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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

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Regulatory & Medical Writing

  • Schedule and prepare for the Pre-NDA meeting
  • Write, edit, and review eCTD modules, CSRs, and Drug label
  • Publish to the NDA to FDA (or appropriate regulatory agency)
  • Respond to agency questions
  • Continued support for safety updates/annual reports

Data and Statistical Analysis

Standardize the clinical trial data into:
  • SDTM Compliant Datasets
  • ADaM Compliant datasets

 

Safety/Pharmacovigilance

  • Develop and negotiate Risk Mitigation plans 
  • Post-Market Pharmacovigilance 
  • Prepare for agency audits and inspections  
  • Set up the PV Systems, processes and training 

 

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.

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When you work with Veristat, you get:

  • An agile interdisciplinary team that is adept at working together to prepare and publish your marketing application ​
  • Achieve your submission timeline- no matter the disruptions​
  • The right expertise at ​the right time (access to expertise when and where you need it) ​
  • A solid agency relationship with Regulatory Agencies to present and defend your marketing application
  • Peace of mind – this is what Veristat does​ best!

 In 2020, Veristat teams supported marketing applications for 10% of all FDA Novel Drug Approvals. 
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Want to ensure a successful regulatory submission process?
Let us help. Contact us today and tell us about your project.

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More Marketing Application and Pharmacovigilance Support

Explore some of our specific expertise for marketing application planning: