Pharmaceutical

Companies operating in the Pharmaceutical sector are constantly under the pressure to develop new drugs to improve the quality of life. Following the lengthy and complex process of drug discovery and clinical trials, a company is required to make a new drug application to U.S. FDA. To gain approval from regulatory bodies, a Pharmaceutical company must demonstrate strict document control and process management relating to the drug research and development. Non-Compliance to these standards might restrict the organization from supplying to certain markets. Additionally, even if they gain approval to market, the companies must confirm to the current Good Manufacturing Practices (cGMP) and ISO requirements for initial large scale production and later to continue serving to the same markets.

Proquis solutions have made it possible for pharmaceutical companies to automate documentation and processes relating to the product development life cycle. This has been achieved through an easy transition to an electronic quality system that is designed to improve regulatory compliance, provide integrated quality system for documents and issues and actions / CAPA, and promote faster change control processes.

If you need an integrated solution that is modular and can be expanded as your needs grow, please contact us to see how our Proquis solutions can take your company to the next level.