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Coping with challenges in drug development

Coping with challenges in drug development

Medium: European Biotechnology
Author: Dr. David Brett, Team Leader, Product and Service Management at Vetter

What are the keys to achieving successful GMP clinical manufacturing on time and within budget? Do regulatory provisions need to be considered? Can the choice of primary packaging selection help to reduce risk and cost? Are there legal and quality issues involved in GMP filling?

The challenges involved in new drug development are growing, and regulatory requirements are becoming more complex. Partnering with an experienced Contract Development and Manufacturing Organization (CDMO) can help prevent issues such as time delays or the need to seek additional funding from arising. There are a number of key aspects that must be considered right from the start from a CDMO perspective to help achieve clinical manufacturing on time and within budget. Dr. David Brett, Team Leader, Product and Service Manager for Vetter, offers insight into this process and provides the reader with a detailed checklist for successful GMP clinical manufacturing.

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Coping with challenges in drug development

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