In this audiocast, the focus is on how Artificial Intelligence (AI) and Augmented Intelligence can impact the regulatory CMC strategies and submissions during drug development. The use of AI-based methods such as predictive analytics and machine learning can help in decision-making regarding quality control, reducing costs associated with corrective action plans, and identifying potential data requirement issues before they become serious problems. The audiocast also highlights an example of how an emerging biotech sponsor used AI-powered software to generate a CMC submission for a new drug candidate, saving time and reducing the risk of errors during the submission process. The audiocast concludes by emphasizing the importance of understanding the specific goals and objectives of the drug development process, selecting the right AI-powered tools, and having the right team in place to harness the power of AI to improve the regulatory CMC process.
In this Audiocast we discusses the common issues that can arise in the pharmaceutical industry, including quality-related issues, adverse events, product complaints, and product recalls. The video provides guidance on how to handle and report these issues, including identifying the problem, conducting a root cause analysis, implementing corrective and preventive actions, and reporting to relevant parties such as regulatory agencies. The video emphasizes the importance of complying with regulatory requirements and keeping detailed records of all aspects of the issue to ensure patient safety.
The AudioCast discusses the key considerations for developing modified-release versions of immediate-release oral solid dosage forms. It covers the selection of release mechanisms, establishment of release profiles, understanding of regulatory requirements, formulation and manufacturing considerations, analytical testing methodologies, BCS classification and biowaiver, clinical development planning, and intellectual property protection. Additionally, it emphasizes the benefits of API characterization and pre-formulation work in terms of improving understanding of API properties, identifying formulation challenges, supporting regulatory submissions, and predicting product performance in the body. Lastly, it mentions the essential CMC development data required by health authorities for evaluating submissions, including formulation development, manufacturing processes, analytical method development and validation, stability data, in-vitro release studies, biopharmaceutical classification system and biowaiver, clinical development plans and data, and comparative data.
In this episode of "Navigating Regulatory Challenges," we are joined by the experts from Enkrisi, a leading regulatory and product development consulting firm. Discover how Enkrisi is helping emerging biotech companies navigate the complex world of regulatory requirements for biologics, pharmaceuticals, and medical devices. Learn about their comprehensive services, including CMC development strategies, regulatory planning, risk mitigation, and engaging with regulatory agencies. Gain insights into the importance of making informed decisions, optimizing spending, and developing a strong package for regulatory approval. Join us as we explore the role of Enkrisi in shaping a better future through innovative approaches, world-class science, and regulatory know-how.