Healthcare

PRODUCTS

  • ProPharma has deep expertise across all signal detection and management activities, including validation, prioritization, and assessment using data from a wide range of sources that are relevant for signal detection for the individual product(s). We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can support MAHs to comply with their obligations for signal detection and management. We leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.

  • Conduct secure video based visits, manage study schedules, and keep participants connected through a single unified platform.

  • Smooth connectivity between your machines and to other systems is a precondition for reliable and secure pharmaceutical production. With the Line Optimizer from Körber enables you to set standards, shape, and control quality-related processes, and optimize the effectiveness of your production line.

  • Enforce standardized workflows while collecting data in real time, giving you the visibility you need to prevent deviations, review exceptions, and release batches faster.

  • There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.

WHITE PAPERS AND CASE STUDIES

NEWS