CMC Regulatory Support

The development of new biopharmaceutical products begins with Chemistry, Manufacturing, and Controls (CMC). The CMC process is crucial for scaling a drug from laboratory bench studies to clinical trials and beyond. Documenting each step along the way ensures that your drug products, substance or formulation will meet regulatory compliance and obtain market approval from bodies like the FDA, EMA, and other global regulatory agencies.

Regulatory support for Chemistry, Manufacturing, and Controls (CMC) is indeed crucial for the successful development and commercialisation of biopharmaceutical products. Proper regulatory oversight helps ensure that biopharmaceutical products are safe and effective for patient use.

• Expertise and Experience
  Our team has an extensive experience in CMC regulatory submissions, particularly in your specific product area (e.g., ATMPs, biologics, small molecules, herbals). With a track record of successful submissions and a deep understanding of regulatory requirements we can support all your needs, from early clinical trial applications to marketing authorization; including ASMF and DMF applications and dossier for CEP certificate.
• Regulatory Knowledge
  We are well-versed with the latest regulatory guidelines and expectations from agencies like the FDA, EMA, EU national and other relevant authorities. This includes knowledge of ICH and regional guidelines.
• Technical Proficiency
  We have a strong technical background in pharmaceutical sciences, including formulation development, process validation, analytical methods, and quality control. This background ensures that we can effectively address technical challenges and provide robust documentation.
• Attention to Detail and Problem-Solving Skills
  CMC submissions require meticulous documentation and adherence to regulatory standards. With a keen eye for detail we can ensure that all aspects of the submission are accurate and complete. Our team has a strong ability to identify potential issues early and develop effective mitigation strategies. This includes troubleshooting manufacturing processes and addressing unexpected regulatory challenges.
• Project Management
  Strong of our project management skills we will help in coordinating various aspects of the CMC submission process, ensuring deadlines are met and resources are efficiently utilised. Our collaborative approach ensures clear communication, timely updates, and a shared commitment to achieving the best possible guidance and support throughout the submission process.

• Regulatory Strategy Development
  Crafting comprehensive plans to navigate the regulatory landscape effectively.
• Documentation and Submission
  Preparing all required documentation to regulatory bodies, from the early development phase (IMPDs and INDs) to marketing authorization requests, including ASMFs, DMFs and dossier for CEP application.
• Lifecycle management
  Managing post-approval changes and ensuring ongoing compliance throughout the product lifecycle.
• Regulatory Liaison
  Acting as a liaison with regulatory agencies to facilitate communication and address any issues that arise during the approval process.
• GAP Analysis
  Evaluating the GAPs between the dossier content and the latest regulatory guideline and expectation to ensure compliance in case of product acquisition or new marketing authorization of already marketed products.

By choosing to work with us, you’re partnering with a team dedicated to effectively support your CMC submission, ensuring compliance and facilitating a smoother approval process. Let’s discuss how we can support your specific needs and help you achieve your goals.