Regulatory

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.

• Qualification, Risk Assessment, and Process Optimization
• Manufacturing and Testing Support

Qualification, risk assessment, and process optimization

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:

• Expediting approval preparation and extending compliance
• Facilitating qualification processes
• Supporting risk assessment, management, and mitigation
• Increasing supply chain transparency
• Saving you time and money

Manufacturing and testing support

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:

• End-to-end solutions that streamline your process and set you on the path to success – whether you are looking to implement proven solutions while reducing costs and mitigating risk or need a partner who will work with you from process development through facility design and construction, anywhere in the world.
• Complete testing solutions for environmental monitoring, traditional and rapid microbial detection, and sterility assurance – critical factors in the manufacture of pharmaceutical or medicinal products and devices that meet the highest quality standards and regulatory demands.

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.