Ensuring that drugs adhere to local, national, and international regulations set by health authorities (FDA in the US, EMA in Europe, etc.).

Preparing and submitting applications, dossiers, and documentation required for drug approval, including clinical trial data, safety information, and manufacturing processes.

Monitoring and ensuring the quality, safety, and efficacy of drugs throughout their lifecycle, including manufacturing practices, labeling, and packaging.

Overseeing and coordinating clinical trials to ensure they meet regulatory standards and ethical guidelines, collecting necessary data for drug approval.

Ensuring that drug labeling, packaging, and advertising materials comply with regulatory requirements and accurately represent the drug’s benefits and risks.

Monitoring drugs once they are on the market, collecting and analyzing adverse event reports, and taking appropriate actions to address safety concerns.

Developing strategies to navigate complex global regulatory landscapes, considering differences in regulations across various regions.

Keeping abreast of changes in regulations, policies, and guidelines and ensuring that the company adapts to these changes effectively. collected data using statistical methods to draw conclusions about the safety and efficacy of the intervention being studied.

Assessing and managing risks associated with drug development, approval, and post-market phases, implementing strategies to mitigate potential issues.