Malpractice in regulatory submissions can compromise product efficacy, safety, and integrity,
negatively impacting health and legal situations. Common types of submissions include clinical trials,
changes to information, marketing applications, and post-approval commitments. The FDA has
tightened submission conditions, with 32% of trial data showing serious problems with data
compliance. To optimize submissions, companies should maintain extensive regulatory knowledge,
stay updated on regulations, guidelines, and standards, and participate in meetings and discussions
before filing. Collaboration between senior management and submission teams is crucial, as unrealistic
deadlines can increase risk. Ensuring regulatory submissions is a complex process that requires
extensive knowledge, effective communication, and a commitment to avoiding malpractice.
Malpractice, characterized by actions that defy standards, bias, and public opinion, is influenced by
weak legislative frameworks, disproportionate company influence, and lack of initiative. Implementing
a structured SOP and staying updated on regulations can help companies navigate the complex process
of regulatory submissions, improving their chances of success.
Keywords: Malpractices, Regulatory Submissions, Optimization, SOP’s
Publication date: 01/08/2025
https://ijbpas.com/pdf/2025/August/MS_IJBPAS_2025_9374.pdf
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https://doi.org/10.31032/IJBPAS/2025/14.8.9374
