Biopharmaceuticals are one of the world’s most regulated environments. As biologics clinical trials grow more complex and costly – accounting for some 90% of clinical trials spending – regulatory requirements can evolve. To stay the course on the journey to commercialization, you must understand the global pharmaceutical regulatory landscapes. Fortunately, there are resources to help you stay ahead throughout your process.
To develop robust processes you need comprehensive and thorough documentation of filters and single-use components, as well as pharma raw and starting materials. Not only must you cover the latest regulatory requirements, but you must also anticipate industry expectations not yet covered by regulation.
One supply chain solution to help you speed your way through the regulatory maze and fast-track your new drug to market is the Emprove® Program, containing over 400 raw and starting materials, more than 30 filter and single-use product families, selected chromatography resins and cell culture media. Each product portfolio is supported with Emprove® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.
The Emprove® Program simplifies your processes by:
To help reduce your risk and make better decisions, leveraging a world-class manufacturing and testing partner can provide the support and expertise you need to accelerate drug development, scale your process, and implement local production facilities globally. Depending on your requirements, the right partner should be able to provide:
The right resources allow you to focus on discovering innovations that may help patients in need. Select any stage of the development process to learn more. Or follow the product and service links for supportive resources offering plug-and-play opportunities at the beginning of your startup creation.
Starting your journey to successful drug discovery, development, and commercialization
Identifying the considerations, resources, and support you need to develop a new biologics candidate
Establishing safety and effectiveness for your Investigational New Drug (IND) application
Progressing from scale-up and tech transfer to quality production for trials and commercialization
Connecting with resources and grant programs that can unlock your molecule’s potential
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