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| Achieving Excellence In The Regulatory Digital Transformation | | The COVID-19 pandemic demanded significant pivots, and technology became critical for continued regulatory operations, including carrying out virtual inspections to assess drug safety and adherence to GMP. Key decision-makers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually. |
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A biotechnology company with limited experience in the development and manufacture of high potency compounds needed to develop a process for producing a highly potent API, a DNA alkylator, used to treat an unmet oncology need, and wanted a partner for pre-clinical development and clinical trial material manufacture. |
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A top 20 US-based pharma company required more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection (PAI). Learn how their CMO partner completed the project for the creation of a new commercial manufacturing facility while achieving the increased volume demand. |
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A top 100 European-based pharmaceutical company sought a development and manufacturing partner to assist with development work and scale-up to commercial manufacturing for a molecule in clinical Phase II/III trials where the chemistry required was particularly challenging. |
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Fostering CDMO Collaboration On Both Sides | Fluid and transparent communication is an essential element of a successful CDMO relationship. Hear an industry expert share his perspective from both the pharmaceutical and CDMO sides of the table on why partnering with a collaborative CDMO can make a significant impact on a program’s success. | • Request Information | | |
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