Business Process Management

PRODUCTS

  • Compliance solutions for product development agility and audit readiness.

  • We want your product to move through the regulatory process, gaining approvals and ultimately helping patients. Using our industry leading knowledge and skills, we will meet you where you are – gaining approval: for the first in human trials, in development, at scientific advice, at the end of phase 2, or post approval. At every level, our scientific expertise and in-depth knowledge of therapeutic backgrounds have guided every client we have to a successful outcome.

  • Immunotherapy is an evolving and promising cancer treatment that works by stimulating the immune system. More biologically relevant human primary cells are now the chosen starting material for immunotherapy development. Historically, scientists routinely used immortalized cell lines in the research and development of therapies as they offer an inexpensive and stable platform. However, they are not fully representative of what is going on in vivo.

  • This gentle peristaltic pump is designed for dispensing shear-sensitive products. It uses pre-sterilized single-use fluid paths that can easily be installed in the pump in an isolated setting through the glove port, ensuring sterility.

  • We support you in the process of optimally implementing complex Manufacturing Execution Systems. In addition to the creation of Master Batch Records (MBRs) and Electronic Batch Recording (EBR), including classic data acquisition and preparation, as well as all other processes that have immediate effects on the manufacturing process.

WHITE PAPERS AND CASE STUDIES

NEWS