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PRODUCTS

  • 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.

  • Our dermatology studies provide results that are more than skin deep. Because the skin is the largest and most easily accessible organ, our dermatology research also facilitates drug development in other areas, including immunology and endocrinology. In addition, we are engaged in studying ways to improve wound healing.

  • Managing documents, training, and business processes are nightmares shared by all pharmaceutical and biotech companies and MasterControl provides pharmaceutical quality management software systems to take them out from that nightmare. MasterControl's QMS software exchanges the nightmares for a dream of a solution that enables pharma companies get their products to market faster and improve compliance at the same time. MasterControl pharma QMS software has been specifically designed to help manage all documents and automate regulatory-related processes and training in a single platform.

  • Solutions for rapid response to vaccine development and manufacturing challenges

    Vaccine development trends emphasize the need for adaptability and accessible production facilities. Remote manufacturing tackles these challenges, facilitating decentralized vaccine production and rapid responses to health crises. Germfree, a leading cleanroom manufacturer, remains at the forefront of these trends by providing configurable solutions that satisfy regulatory requirements and end-user needs. By leveraging innovative remote manufacturing technologies, Germfree helps shape a more dynamic and efficient future for vaccine development and production.

  • How you capture study data can make or break your organizational success, so why settle? Medrio’s EDC technology is intuitive, scalable, and proven across over 8,000 studies.

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