Introduction to Enkrisi: Learn about Enkrisi, a full-service regulatory and product development consulting firm, specializing in biologics, pharmaceuticals, and medical devices. Understand their mission to help companies bring innovative and safe products to the U.S. market.

The Complexities of Product Development: Explore the challenges faced by emerging biotech companies in navigating the regulatory landscape. Understand the importance of establishing a concise CMC development and regulatory strategy to ensure successful product development.

Optimizing Spending and Mitigating Risks: Discover Enkrisi's approach to helping companies make informed decisions while keeping spending to a minimum until critical clinical milestones are met. Learn how they identify and mitigate associated risks to ensure a smooth regulatory process.

Engaging with Regulatory Agencies: Gain insights into the expertise of Enkrisi's team in approaching regulatory agencies. Understand the importance of having a strong regulatory package to achieve approval and bring products to market.

The Enkrisi Difference: Delve into the philosophy behind Enkrisi's founding and their commitment to a better future through innovative approaches, world-class science, and regulatory know-how. Learn how they become trusted partners in the journey toward regulatory success and product development excellence.

Closing Thoughts: Recap the key takeaways from the episode and highlight the value of Enkrisi's services for emerging biotech companies seeking regulatory approval for their products.

Join us in this episode as we dive into the world of regulatory challenges and gain valuable insights from Enkrisi, your trusted partner in navigating the complex realm of biologics, pharmaceuticals, and medical devices.

When developing modified-release oral solid dosage forms, important considerations include selecting the appropriate release mechanism, establishing the optimal release profile, understanding regulatory requirements, addressing CMC considerations related to formulation, manufacturing, and testing, considering BCS classification and biowaiver, developing a clinical development plan, and protecting intellectual property. API characterization and pre-formulation work provide benefits such as improved understanding of API properties, identification of formulation challenges, support for regulatory submissions, enhanced process understanding, better manufacturing control, and improved prediction of product performance in the human body. Health authorities expect to see key CMC development data, including formulation details, manufacturing processes, analytical method development and validation, stability information, in-vitro release studies, BCS classification and biowaiver status, clinical development plan and data, and comparative data. These data are necessary to demonstrate the suitability and quality of the modified release product for regulatory approval.

Quality-related issues, adverse events, product complaints, and recalls are common in the pharmaceutical industry, occurring at any stage of manufacturing. Issues can arise from raw materials, equipment, or processes, leading to contamination, labeling errors, or deviations. Adverse events include allergic reactions and side effects, while product complaints involve problems reported by customers. Recalls involve the voluntary or mandatory removal of products due to safety concerns. Handling and reporting these issues require steps such as identification, containment, root cause analysis, reporting, and record-keeping. Regulatory requirements may vary, so consulting with relevant agencies is recommended.