From clinical development through post-marketing, we perform rapid and precise safety assessment and pharmacovigilance activities at every stage. Safety information for pharmaceuticals is not only directly linked to patient health but is also a critical component in meeting the stringent requirements of regulatory authorities. We provide an integrated safety management solution compliant with international pharmacovigilance standards, Good Pharmacovigilance Practice (GVP), as well as country-specific regulatory requirements.

We have a systematic system in place for collecting, evaluating, and reporting Adverse Events and Adverse Drug Reactions, and our experienced pharmacovigilance experts review and analyze all safety information. We also support periodic safety updates, such as Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs), as well as the development of Risk Management Plans (RMPs), enabling continuous monitoring and management of the safety profile throughout the entire product lifecycle.
This ensures the safety of pharmaceutical products and helps our customers comply with regulations and successfully manage their products.

We provide integrated pharmacovigilance services that comply with the regulatory requirements of major authorities, including the Korean MFDS, the U.S. FDA, and the European EMA. Through continuous monitoring and review of the evolving global regulatory landscape and the latest guidelines, we support our clients' pharmaceutical products in reliably meeting the legal requirements of each country.

By aligning with the review focus and practical practices of each regulatory authority, we establish proactive and strategic safety management plans to enhance the likelihood of approval and minimize potential risks that may arise during regulatory inspections and approval reviews. This approach supports the successful development of pharmaceuticals and ensures smooth post-marketing management.

Ensuring drug safety after market launch goes beyond fulfilling reporting obligations and is a critical element in maintaining patient safety and trust. Based on Real-World Data (RWD) collected post-marketing and voluntary reporting, we analyze and assess adverse events.

Through this process, we can identify potential risks at an early stage and provide scientific evidence to support follow-up measures, such as changes to product labeling, the addition of warning statements, or product recalls when necessary.
Such comprehensive post-marketing pharmacovigilance contributes to enhancing the reliability and competitiveness of a product throughout its entire lifecycle.