Regulatory affairs, one of the most critical steps in drug development, is a highly regulated, complex, and time-consuming process. Preparing documents, keeping up with constantly evolving regulations, and managing multinational procedures place a significant burden on pharmaceutical companies in terms of time, cost, and resources. Additionally, the lack of standardization in global markets further complicates the process.

Pharmaceutical companies must prepare hundreds of documents, follow country-specific regulatory requirements, and continuously adapt to ever-changing legislation. Today, regulatory processes are still largely carried out using traditional methods. Many pharmaceutical companies continue to manage these processes by:
➤ Relying on internal teams or foreign affiliates
➤ Working with external experts and consultants