CMC Registration Support
BOC Sciences has extensive experience in CMC registration filings. Our application team is familiar with the drug regulatory systems of the United States, the European Union, WHO, China, Japan, Brazil and other countries, and can provide global customers with CMC application services at all stages, including investigational new drug applications and P1, P2, P3 Clinical trials, new drug and generic drug marketing applications.
As the world's leading chemical drug CDMO company, our drug filing department focuses on helping you solve complex and cumbersome documentation and minimize the filing time. We have helped many clients complete more than 100 IND applications, with a 100% success rate. Before starting the declaration, we will conduct close and detailed communication with customers to fully grasp their needs and requirements. A dedicated team will then support you from project initiation, providing gap analysis, preparation, revision and submission of CMC documents until your drug is finally approved.
What is CMC Registration?
Chemical, Manufacturing and Control (CMC) is one of the key elements for the successful development and registration of products and is a very important part of drug application materials. It usually refers to the development and production process of pharmaceuticals, including chemical composition, production processes and quality control measures. CMC covers the entire process from the initial development of APIs to final pharmaceutical products. It encompass a multitude of facets, including the meticulous selection of raw materials, the intricate manufacturing process, and the rigorous testing and release of the final product. Regulatory agencies maintain a vigilant watch over the CMC to ensure the utmost safety, efficacy, and quality of medicinal products. CMC registration of drugs stands as a pivotal process, involving the meticulous registration of drugs with regulatory agencies such as FD A or EMA. This intricate process necessitates the provision of comprehensive and intricate details regarding the chemical composition, manufacturing process, and stringent quality control measures of the drug. These regulatory entities use this complex information to carefully evaluate the safety, efficacy and quality of drugs.
IND Declaration Process
Investigational new drug application (IND) is a request for F DA to authorize the application of research drugs to humans. The CMC information in IND generally includes information such as the composition of raw materials and preparations, production processes, analytical methods, stability studies and production control, and placebos. The IND application also includes information on the pharmacology, toxicology and pharmacokinetics of the drug, as well as any previous human experience with the drug. This information is critical to the F DA's assessment of the quality and consistency of drugs to be used in clinical trials. The IND application submission process involves several key steps, including preparing an IND application, submitting an application to the FD A, and responding to any questions or additional information requests from the F DA. The following is an overview of the IND application submission process:
Our CMC Registration Services
BOC Sciences is committed to providing customers with the highest quality registration services, our services include but are not limited to:
Preparation of Filing Materials from IND to NDA
- Prepare application materials according to the list of materials
- Prepare and write submissions from a reviewer's perspective
- Assist clients to complete document submission
- Interpret the latest regulations and provide peer-to-peer consulting services
- Provide compliance guidance and support during the CMC production phase
Develop Reporting Strategy
- Develop global registration strategies
- Limited avoidance of reporting risks, saving time and costs
Build Communication Mechanism
- Prepare and participate in various formal meetings with the agency, such as Pre-IND meetings, pre-NDA/BLA submission meetings
- Organize the minutes of the meeting, record the opinions and discussion results of the issues in the meeting
CMC Process Research Support
Drug substance: Fully study the properties of drug compounds. On the one hand, a comprehensive understanding of the properties of compounds can provide an important basis for selecting dosage forms, prescriptions, synthesis processes, etc. On the one hand, a comprehensive understanding of the properties of compounds can provide an important basis for selecting dosage forms, prescriptions, synthesis processes, etc. On the other hand, clarifying the structure of the compound can ensure the stability of the compound, reduce the introduction of impurities and clarify issues such as genetic toxicity. In addition, it is necessary to formulate internal control standards for the sources and specifications of starting materials, reagents and organic solvents. According to the possible by-products, the reaction conditions were optimized to reduce the generation of impurities and determine the control standard of intermediates.
Drug product: Since the prescription and specifications of the drug are relatively clear, detailed research on the preparation process is required. Find out the differences in the amplification process in advance, determine the parameters of the key process, and fully prepare for future commercial production at each step.
Excipient packaging materials: Develop management procedures for the purchase, storage, distribution, and use of raw materials, excipients, and packaging materials used in the production of clinical trial drugs, and establish relevant supplier procedures with full consideration of safety factors.
Quality control: In the comprehensive development stage, the process and specifications of CMC quality research for generic drugs can be referenced as much as possible. The impurities in the drug need to be qualitatively and quantitatively determined, and their limits should be determined according to the relevant research results. Detailed methodological studies are needed for the examination of related substances and content determination to investigate the feasibility of the method.
Highlights of Our CMC Registration
- BOC Sciences firmly controls every link of drug registration, integrating a complete set of production processes, key steps, physicochemical properties, analytical methods, quality control, stability, pharmacology and toxicology studies required for IND and NDA submissions service.
- We are able to maintain and update CMC's historical documents to ensure the accuracy of the data and to align it with the latest guidelines.
- Before submitting an application, we conduct a comprehensive review of the application materials, and ensuring high-quality application documents is one of the key reasons for our consistent success.
- BOC Sciences has also established a well-established communication channel with the drug review department. Timely communication helps to deeply understand technical and regulatory issues, so that the application materials can be revised and improved in a timely manner.
In addition to CMC registration support, we also provide project management, quality assurance, quality control and stability analysis services for quality studies of drugs. If you are interested in our CMC registration support services, please contact us immediately.