March 10, 2025
The DNA of a life sciences business must believe that a substantial value for quality must be fully expressed in its DNA. Quality Culture is essential in healthcare; it directly impacts patient outcomes and operational efficiency. This article will describe the importance of preserving quality culture after an acquisition. The Role of Mergers and Acquisitions in […]
March 3, 2025
The Quality Assurance (QA) function is pivotal during due diligence in the life sciences industry. QA professionals play a critical role in ensuring compliance, identifying systemic risks, and validating the integrity of operations. This guide outlines the essential QA tasks during due diligence and provides a targeted approach to evaluating and remediating quality-related gaps. Know […]
February 26, 2025
I worked for a Chief Quality Officer several years ago who always had this response when our company was contemplating the movement of a large volume of internal production to third parties: “You can delegate your responsibilities but never delegate your accountabilities.” He was a wise man. The Growing Complexity of Third-Party Management I have […]
February 17, 2025
Selecting a contract manufacturer to produce your product is critical in any pharmaceutical/biopharma or medical device company. Whether you are a small Cell Therapy or Gene Therapy Start-up, a small to mid-size Medical Device company, or a large global Pharmaceutical/Biopharmaceutical or Medical Device firm. Selecting a contract manufacturer is a strategic decision that is part […]
February 10, 2025
Biologics, MedTech, and Pharmaceutical organizations rely on Contract Development and Manufacturing Organizations (CDMOs) for various segments of their supply chains due to the numerous strategic and operational advantages they offer. CDMOs provide specialized expertise, state-of-the-art facilities, and advanced technologies that these organizations might not possess in-house. By outsourcing to CDMOs, companies can focus on their […]
February 3, 2025
Partnerships with Contract Development and Manufacturing Organizations (CDMOs) have become increasingly essential in the complex and highly regulated manufacturing world. These collaborations allow companies to efficiently bring products to market by leveraging CDMOs’ specialized expertise, capacity, and technology. However, the success of such partnerships hinges on a clear and robust quality agreement, especially in the […]
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