Navigating the evolving regulatory landscape can be a challenge, especially for early-stage biotechnology companies developing a drug for the first time. The production process for new drug candidates is governed by a stringent and extensive set of requirements to which every manufacturer must adhere. Regulations, guidelines, and expectations are published by a range of global agencies and organizations such as the FDA, EMA and USP, and include GMP, ISO, and CRF requirements.
Understanding and properly applying these regulations are critical to success and avoiding unnecessary delays. If the choice is to outsource development and manufacturing to a CDMO, knowledge of fundamental regulatory terminology is essential as the drug candidate advances towards commercialization or possible acquisition by a pharmaceutical partner.
Biologics account for some 90 percent of clinical trials spending and continue to grow more complex, costly, and risky to develop. In this environment, biotech companies need help navigating regulatory requirements.
The MQ levels of the M-Clarity™ Program provide transparency so that you can choose, with confidence, suitable products that meet your needs.
Quality is embedded in everything we do, meaning we provide quality, compliance and business support in the most effective and efficient way for the entire portfolio of our life science business.
Learn about the importance of raw materials selection, and strategies for choosing fit-for-purpose raw materials. Discover how programs like M-Clarity™ and Emprove® can provide transparency, traceability, and comprehensive documentation for raw materials.
Explore FDA’s guidance on IND applications, a crucial step in drug development for biotech startups. Navigate regulatory intricacies efficiently.
Dive into this invaluable resource for biotech startups, offering data on global clinical trials for strategic decision-making.
To develop robust processes, you need comprehensive and thorough documentation of raw materials, starting materials, filters, and single-use components. The documentation should not only cover current regulatory requirements, but help you anticipate possible changes not yet defined in the regulations.
You can accelerate your way through the regulatory maze and get your new drug to market faster with the Emprove® Program. This program encompasses more than 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:
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 developing and manufacturing new drugs for patients in need. Select any stage of the development process below to learn more. Or follow the product and service links for specific information about how we can help.
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