The VirtualPharm

This podcast presents ten crucial questions for emerging biotech companies to consider when reviewing their Chemistry, Manufacturing, and Controls (CMC) strategies at year-end. The questions cover various aspects, including regulatory milestones, data analytics, risk management, quality assurance, and future goals. Each question includes examples illustrating its importance for successful drug dev...

Cracking the Code   CMC Regulatory Compliance in Early Drug Development   Summary  This two-part blog post and podcast series provides a guide for small biotech companies on navigating Chemistry, Manufacturing, and Controls (CMC) regulatory compliance during drug development. It emphasizes the importance of strategic CMC planning, risk assessment, and early engagement with regulatory authorities f...

This Podcast offers a structured approach to setting drug specifications when data is limited. It emphasizes a risk-based strategy using industry standards and conservative initial ranges, iteratively tightened as more data becomes available. The process includes focused data collection, regulatory compliance, and Quality by Design principles. Cross-functional collaboration and thorough documentat...

This guide explains how to create a high-quality CMC Quality Module 3 and Quality Overall Summary (QOS) for a New Drug Application (NDA) submission to the FDA.  It emphasizes the importance of these documents for regulatory compliance, accelerated approval, and demonstrating product quality.  The guide provides a step-by-step process, including best practices and common pitfalls to avoid, and high...

The podcast explains the complexities of the  Regulatory Chemistry, Manufacturing, and Controls (CMC)  process in drug development by drawing an analogy to the popular board game Monopoly. The author compares various aspects of the CMC process, like pre-IND planning, formulation development, and regulatory interactions, to actions taken while playing Monopoly. The text also highlights the crucial...

This Podcast discusses the critical role of  API process development  in the  Chemistry, Manufacturing, and Controls (CMC) drug development process . This process focuses on ensuring the  drug substance or API (Active Pharmaceutical Ingredient)  can be  manufactured consistently and safely  at scale. The text explains the different stages of API process development, from the early preclinical phas...

The Podcast focuses on how technology, specifically augmented intelligence (AI), can improve the efficiency and compliance of drug development. The article emphasizes the importance of technology in streamlining back-office operations and supporting the regulatory aspects of Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical companies. The text highlights how AI-powered solutions can...

The podcast provides an overview of drug substance and product stability testing. They describe the importance of stability testing for ensuring product quality and safety. The texts highlight the complexity of FDA stability guidelines, which are intended to provide general principles for conducting stability testing. The sources then outline the specific guidelines for stability testing establish...

The provided text focuses on the complexities of regulatory drug development and emphasizes the importance of a comprehensive and dynamic strategy document, particularly in the area of chemistry, manufacturing, and controls (CMC). This document helps streamline the process by providing a visual representation of the various stages of drug development, allowing for effective communication, tracking...

The podcast provides guidance on creating a successful Common Technical Document (CTD) application for drug approval, specifically focusing on Quality Module 3. It emphasizes the importance of clarity, accuracy, and thorough documentation in presenting scientific data to regulators. The document highlights the need for a cohesive narrative within Module 3 to demonstrate the drug's quality and...

The podcast discusses the International Council for Harmonisation (ICH) guidelines and their impact on pharmaceutical development. Specifically, the text focuses on the key updates to the ICH guidelines, including Q2(R2)/Q14 for analytical validation, Q5(R2) for viral safety evaluation, and Q9(R1) for quality risk management. The text also examines the ICH's efforts to address emerging techno...

The International Council for Harmonisation (ICH) has updated its guidelines on quality risk management (QRM) with ICH Q9(R1). This update emphasizes a more proactive and structured approach to risk management in the pharmaceutical industry, emphasizing reducing subjectivity and integrating knowledge into risk-based decision-making. The update encourages the use of digital tools and emerging techn...

This Podcast is a guide to authoring a successful CMC Quality Module 3 and Quality Overall Summary (QOS) for a New Drug Application (NDA) submission to the Food and Drug Administration (FDA). Ethan and Desi detail the importance of these documents for demonstrating a product's quality, navigating the regulatory review process, and achieving global market access. They also provides best practi...

This podcast covers the common regulatory challenges faced by professionals working in the pharmaceutical and biotechnology industries. The authors provide seven scenarios, ranging from an unexpected clinical hold to difficulty obtaining budget approval for regulatory activities, and present solutions for each. These solutions include strategies for effective communication with regulatory agencies...

 The podcast episode explores the development of robust stability protocols for Chemistry, Manufacturing, and Controls (CMC) submissions within New Drug Applications (NDA) or Biologics License Applications (BLA). It emphasizes aligning stability protocols with regulatory guidelines from bodies like the FDA and EMA, focusing on key aspects like study design, storage conditions, analytical method va...

 The episode "Strategic Timing for Defining Regulatory Starting Materials (RSMs)" highlights the impact of timing when defining RSMs during Active Pharmaceutical Ingredient (API) development. It examines three stages—Pre-IND, Post-IND but pre-clinical trials, and late development before submission—each with its own advantages and challenges. Early-stage definitions offer flexibility but...

The source is a guide to the field of Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA) within the pharmaceutical industry. It explains the role of CMC RA in ensuring drug development, manufacturing, and marketing comply with regulatory standards. The source details the key functions of CMC RA, such as regulatory strategy development, submission management, and compliance monito...

This article argues that  strategic outsourcing, particularly for Small Molecule APIs, is a key component of successful drug development . It outlines the benefits of outsourcing for pharmaceutical companies, including cost reduction, increased focus on R&D, and faster time-to-market. The article also emphasizes the importance of  regulatory strategy  and highlights how Enkrisi, a company spec...

In this podcast, Desi and Ethan discuss the importance of a robust Global CMC regulatory strategy for pharmaceutical companies seeking global market access. It emphasizes the need to understand the regulatory requirements of each target market, harmonize CMC data and documentation across regions, and establish a comprehensive quality system. The article also highlights the role of the Internationa...

This excerpt from "Robust CMC Process for Small Molecules" is a guide to designing robust manufacturing processes in the pharmaceutical industry. It highlights the importance of comprehensive planning, rigorous design, and continuous improvement in the development of small molecules, biologics, and dosage forms. The author stresses that a robust process development strategy is critical f...

Podcast Description: In this episode, we explore the essential components of a robust Chemistry, Manufacturing, and Controls (CMC) due diligence framework, with a special focus on drug substance evaluation. Join us as we break down the comprehensive steps involved in conducting due diligence during pharmaceutical acquisitions or in-licensing. From regulatory compliance to technical assessments, we...

  Welcome to "Accelerating the Path to Approval", hosted by Ethan and Despina from Enkrisi. In this podcast, we explore the critical steps in developing a robust Regulatory Chemistry, Manufacturing, and Controls (CMC) strategy that can make or break a successful New Drug Application (NDA) or Biologics License Application (BLA) submission.   Today, we’ll be diving into the 5 Strategic Ste...

 In this insightful episode, hosts Ethan and Desi take you on a deep dive into the drug approval process, emphasizing the critical role of Chemistry, Manufacturing, and Controls (CMC) documentation. With a focus on what sponsors often miss, the discussion highlights how inadequate preparation in key areas like stability studies, process validation, and facility readiness can lead to costly delays...

We are excited to announce the launch of our brand-new podcast, The VirtualPharm: The Regulatory Intelligence Podcast —where we bring Regulatory CMC to life! 🎉 Hosted by industry veterans with decades of experience, The VirtualPharm dives deep into the most pressing and complex topics in Chemistry, Manufacturing, and Controls (CMC). Whether you're navigating the latest FDA regulations, prepa...