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REGULATORY INTELLIGENCE

SYSTEMATIC PROCESS, EFFECTIVE DECISIONS

Regulatory Intelligence is the process of systematically collecting and analyzing the latest regulatory updates that impact an organization’s operations, in order to ensure compliance. It involves processing targeted information and data from multiple sources, analyzing the data in its relevant context, and generating a meaningful output, such as outlining risks and opportunities, to the regulatory strategy.

Regulatory Intelligence is a core task of regulatory affairs and provides strategic information that underpins the making of effective and efficient decisions in relation to the regulatory aspects of the business. Regulatory Intelligence is the foundation of a quality culture. It sets expectations for drug development processes that are sound — prioritizing safety of participants, ethical conduct, and integrity of the data generated.

  • REGULATORY STRATEGY

  • INTELLIGENCE SURVEILLANCE

  • DATA COLLECTION AND INTEGRITY

  • RISK VS OPPORTUNITY ANALYSIS

  • EFFECTIVE DECISION MAKING

  • FIT-FOR-PURPOSE

FOUNDATION FOR QUALITY CULTURE

Regulatory Intelligence is the basis for setting a client’s quality culture. Through this process, expectations are outlined to allow deep understanding of drug development processes that are sound, prioritize the safety of participants, promote ethical conduct, and ensure the integrity of the data generated.

UNDERSTAND AND INTERPRET EXPECTATIONS

Our consultants offer comprehensive expertise across GxP regulations and best practices. They partner with clients to help them understand and interpret Regulatory Agencies’ expectations.

FIT-FOR-PURPOSE CUSTOMIZATION

RegDev consultants possess many years of industry expertise and in-depth knowledge of best practices to assist clients in developing a fit-for-purpose customization of their quality/regulatory processes.

Team Member Insight

Regulatory Intelligence helps clients to identify and assess regulatory risks associated with their products and processes. By understanding these risks, clients can develop strategies to mitigate them and reduce the likelihood of regulatory issues arising. Guiding clients to take proactive steps to ensure compliance and mitigate risks is highly beneficial.”

—   Brian Farnan
Principal Consultant