Ready, Set, Submit! A Regulatory Submission Readiness Checklist

One of the most pivotal steps in the clinical development process is submitting a successful marketing application. A culmination of often years of work, the rejection or delay in reviewing an application (NDA, BLA, etc) by a regulatory authority can set pharma companies back months in terms of work and analysis progress.

In an attempt to develop products that are safe and effective, regulatory requirements for clinical trials across the pharmaceutical industry have continued to evolve, creating an ever-changing set of requirements that pharma companies must adhere to. Ensuring that all of the key clinical data and documents included in your application meet these requirements can take vast amounts of time and effort. 

NDA Submission Requirements

The FDA requires pharmaceutical companies to submit several document types containing information that establishes a study’s traceability. Such documents include:

• Case Report Forms (CRFs)
• define.xml files
• Complete datasets for all trials
• Reviewer’s guides

These documents must be submitted to ensure compliance with all clinical trial GCP guidelines.

Failure to meet technical criteria, such as providing datasets upon which analysis has been based on, can result in a technical criteria rejection. As of 2018, approximately 30% of organizations are rejected based on technical criteria when submitting applications to the FDA. Such rejections can occur when an organization is ill-prepared for the amount of work setting up the clinical trial application process can require, and can easily be avoided with proper workflow.

Internal Submission Strategies

Successful NDAs require more than documentation. Setting a submission up for success starts internally, with strategically planned processes, data standards, timelines, and regulatory interactions. If your organization is ill-equipped to stay on top of evolving regulations, continual system and data compliance, and standards that support effective analysis, your submission may be destined for rejection from the start.

However, there are ways to stay confident about your data’s integrity, compliance, and future approval. Ensure that both the content of your submission and your internal data standards are aligned with regulatory expectations before its time to submit with the Submission Readiness Review by d-wise., an offering designed to help small- to medium-sized pharma and biotech companies ensure their submissions meet regulatory requirements from beginning to end.