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Process Development and Regulatory Consulting ServicesFor over 10 years the Fast Trak™ group at GE Healthcare has assisted companies with process development and industrial scale chromatography issues.
Our Process Development Services offer hands-on downstream process development and optimization and trouble shooting services. We are used to working under strictest confidentiality and projects can be run either at your own facility or at one of our Fast Trak regional centers.
Fast Trak provides custom-tailored services that leverage upon our complete product range of down stream products to provide you the skills and tools necessary to develop a cost-efficient cGMP compliant manufacturing process.
The BioProcess™ Guide offers ongoing support for process development. The Guide is a web-based knowledge source that provides a structured approach to drug development by focusing on optimal production process design with respect to safety, robustness, quality, scale up, cGMP compliance and economy.
Regulatory Consulting, Advice & Audits: Both newly started and well established companies are challenged by the demands of regulatory agencies and the need to ensure biopharmaceutical product quality and safety. Fast Trak can save you time and money through expert advice or internal reviews and audits on a range of topics:
Typically, we arrange a first visit to define the nature and scope of the activity, time-lines and deliverables. Follow-up may require deeper discussions, on-site reviews, generation of reports and recommendations. Contact us via your local sales representative or at one of our regional centers.
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