Regulatory

Icon for discovery phase of new drug development

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.



Qualification, risk assessment, and process optimization

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:

  • 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

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:

  • 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 looking for 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 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.


Biotech Hub Resources Workflow

Biotech Resource Hub

Biotech Resource Hub

Starting your journey to successful drug discovery, development, and commercialization

Discovery

Identifying the considerations, resources, and support you need to develop a new biologics candidate

Pre-clinical

Establishing safety and effectiveness for your Investigational New Drug (IND) application

Phase III and Manufacturing

Progressing from scale-up and tech transfer to quality production for trials and commercialization

Phase I–II

Accelerating your process development with tips, templates, and application guides

Startup Programs

Connecting with resources and grant programs that can unlock your molecule’s potential