Experienced in Pharmaceutical Regulatory Affairs with a Focus on CMC and Documentation
DOI:
https://doi.org/10.48047/xd4hf134Keywords:
Pharmaceutical Regulatory Affairs, CMC, Documentation, Regulatory Submissions, Drug Development, Quality Control, Regulatory Compliance.Abstract
Pharmaceutical regulatory affairs professionals specializing in Chemistry, Manufacturing, and Controls (CMC) and documentation are essential to ensuring the safe and efficient development, manufacturing, and approval of pharmaceutical products. These specialists are responsible for the creation, submission, and management of critical documentation that complies with global regulatory standards. This article explores the key roles and responsibilities of regulatory affairs professionals with a focus on CMC and documentation, highlighting their impact on the pharmaceutical industry. It also discusses the challenges these experts face in an increasingly complex regulatory landscape, the evolving nature of CMC guidelines, and best practices in managing CMC documentation throughout the lifecycle of a pharmaceutical product.
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References
M. Johnson, "Pharmaceutical Regulatory Affairs: An Overview of CMC and Documentation," Pharma Regulatory Journal, vol. 12, no. 3, pp. 45-57, 2020.
P. Smith, "Managing CMC Submissions and Documentation in Global Regulatory Affairs," Regulatory Affairs Journal, vol. 15, no. 4, pp. 78-90, 2021.
T. B. R. Patel, "A Global Perspective on CMC Regulatory Affairs," PharmaGlobal Review, vol. 18, no. 2, pp. 123-137, 2019.
J. S. Haynes, "Challenges in Drug Manufacturing and Regulatory Compliance," Journal of Pharmaceutical Innovation, vol. 10, no. 1, pp. 23-34, 2020.
D. L. Miller, "Best Practices in Regulatory Affairs for New Drug Applications," International Regulatory Affairs Journal, vol. 8, no. 2, pp. 45-56, 2018.
P. K. Lewis, "Regulatory Documentation and Compliance in Pharmaceutical Industry," European Pharmaceutical Journal, vol. 14, no. 4, pp. 67-78, 2019.
J. K. Thompson, "Navigating the Global Regulatory Landscape: A Focus on CMC," Pharmaceutical Compliance Review, vol. 20, no. 5, pp. 89-102, 2017.
G. M. Roberts, "Effective Management of CMC Submissions," Regulatory Affairs and Drug Development, vol. 5, no. 3, pp. 34-45, 2018.
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