Glossary
Submission Validation
What is submission validation?
Submission validation refers to the process of verifying and ensuring the completeness, accuracy, and compliance of regulatory submissions made by pharmaceutical companies to regulatory authorities like the FDA or EMA.
What are the key components of submission validation?
- Verification of all required sections, forms, and supporting documents are included in the submission package.
- Checking that all data, information, and responses are accurate, consistent, and align with regulatory requirements.
- Ensuring the submission adheres to formatting, naming conventions, and electronic submission specifications.
- Confirming that any changes or updates to the submission are properly tracked and incorporated.
What are the benefits of submission validation?
- Improves the chances of a successful first-cycle review by the regulatory agency
- Reduces the risk of delays, information requests, or rejection due to submission deficiencies
- Enhances the overall quality and compliance of the regulatory submission
- Streamlines the review process and facilitates timely approval of the product
What are the different types of submissions validated in pharmaceutical industry?
- New Drug Applications (NDAs): Submissions for approval of a new pharmaceutical product for marketing
- Abbreviated New Drug Applications (ANDAs): Submissions for approval of a generic version of an existing drug
- Biologics License Applications (BLAs): Submissions for approval of biological products, including vaccines, blood products, and gene therapies
- Investigational New Drug Applications (INDs): Submissions to obtain permission to start clinical trials for a new drug or biologic
- Supplemental New Drug Applications (sNDAs) and Supplemental Biologics License Applications (sBLAs): Submissions for changes to an already approved drug or biologic, such as new indications, formulations, or manufacturing processes.
How does submission validation ensure regulatory compliance?
Submission validation is a critical step in ensuring regulatory compliance. It involves checking if a submission meets the necessary standards, requirements, or rules to be validated. This process is essential for regulatory submissions, which contain information for regulators to assess a product’s efficacy and safety. By validating submissions, organizations can reduce the risk of rejection by regulatory bodies such as the FDA. Additionally, submission validation helps maintain data integrity and ensures that all necessary information is provided, reducing back-and-forth correspondence.
