The regulatory consequences for data integrity violations can be severe. Operations can be shut down, management can be held criminally liable, and the negative impact on stock prices, product sales, customer loyalty, and patient safety can lead to lawsuits and even bankruptcy. Take this three-pronged approach to detecting, preventing, and correcting DI lapses.
Integrating clinical and regulatory functions from an early stage adds value to your product, reduces costs...
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Integrating clinical and regulatory functions from an early stage adds value to your product, reduces costs and ultimately produces a sharper, more compelling value story.
A sound Identification of Medicinal Products (IDMP) compliance strategy confers business advantage as it results in high quality, harmonized data that can be queried efficiently.
Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle. A structural commitment to data quality is the only clear route to achieve a competitive advantage.
Smart companies realize that improving data systems and quality metrics is not simply a matter of compliance; it's about transforming their business.
Learn five risk-mitigation strategies to produce data-rich trials, better teamwork and more regulatory interaction.
Successfully leverage the FDA’s accelerated pathways to reach the market more quickly and enhance commercial prospects.
To get the most out of pre-submission meetings and avoid misunderstandings follow this new framework.
While the advantages of seeking and adhering to the advice given by the EMA are clear, there are also several possible drawbacks you can avoid with these key strategies.
Ensure expedited regulatory approval effectively translates into reimbursement and patient access.
Learn the top reasons drugs fail to be recommended for market access.