Chemistry, Manufacturing & Controls (CMC)
At CERES Regulatory Services, our role extends to the detailed physicochemical characterization and structure elucidation of your product, providing a solid foundation for your development and regulatory strategy. Our experts ensure thorough documentation of product properties, leveraging state-of-the-art technologies and methodologies to unravel complex molecular structures and interactions.
CERES Regulatory Services
Expertise in Analytical Development and Validation
CERES Regulatory Services is at the forefront of delivering unparalleled expertise in analytical methods development and validation, offering a comprehensive suite of services designed to ensure your product’s quality assessment is both robust and compliant. With a deep understanding of Chemistry, Manufacturing, and Controls (CMC), our team excels in preparing and aligning CMC sections for global regulatory submissions, meticulously tailored to meet diverse regulatory requirements worldwide.
Our proficiency extends to the development of sophisticated analytical methods that are not only precise and accurate but also reproducible and robust across various matrices. Our team is skilled in navigating the complex landscape of method validation, ensuring that each method is rigorously tested to meet international standards and regulatory expectations for specificity, sensitivity, linearity, accuracy, and precision.
CERES Regulatory Services
Designing Stability Studies for Product Robustness
CERES Regulatory Services specializes in designing comprehensive stability studies that meticulously demonstrate your product’s robustness and predict its shelf life. Our strategic approach to stability testing encompasses real-time, accelerated, and stress conditions, ensuring a thorough understanding of product stability under diverse environmental factors.
CERES Regulatory Services
Physicochemical Characterization and Structure Elucidation
Our role extends to the detailed physicochemical characterization and structure elucidation of your product, providing a solid foundation for your development and regulatory strategy. Our experts ensure thorough documentation of product properties, leveraging state-of-the-art technologies and methodologies to unravel complex molecular structures and interactions.
CERES Regulatory Services
Efficient and Compliant Manufacturing Processes
We understand the critical importance of scalable and compliant manufacturing processes in the success of your product. Our team offers strategic insights into process optimization, ensuring efficiency, scalability, and compliance with regulatory standards. We support the preparation of Drug Master Files (DMFs) and handle global submissions, including EDMF, CDMF, IND, NDS, and Certificate of Suitability, with precision and expertise.
CERES Regulatory Services
Comprehensive Post-Approval Support
Beyond initial approval, CERES Regulatory Services provides ongoing post-approval support, including the preparation of Annual Reports, Prior Approval Supplements (PAS), Changes Being Effected (CBE) supplements, and Type I and II variations. Our commitment to your product’s lifecycle ensures continuous compliance and adaptability to regulatory changes.
CERES Regulatory Services
Innovative Pre-Formulation and Formulation Optimization
Our involvement spans pre-formulation studies and formulation optimization, employing cutting-edge technologies and methodologies to enhance product efficacy, stability, and patient compliance. Our development reports are meticulously prepared, offering detailed insights into formulation strategies and outcomes.
CERES Regulatory Services
Process Validation and Report Preparation
We excel in designing and executing process validation studies, providing comprehensive documentation that meets regulatory scrutiny. Our approach ensures that your manufacturing processes are not only efficient but also reproducible and compliant with regulatory standards, paving the way for successful product commercialization.
CERES Regulatory Services
Why Choose CERES Regulatory Services?
Choosing CERES Regulatory Services means partnering with a team of experts whose commitment to quality, compliance, and innovation sets them apart as the premier choice for regulatory CMC consulting services. Our tailored approach, combined with our extensive experience and global expertise, ensures that your product not only meets regulatory requirements but also exceeds them, facilitating a smoother path to market approval and commercial success.
At CERES Regulatory Services, we’re not just consultants; we’re your strategic partners in achieving excellence. Let us navigate the complex regulatory landscape together, transforming challenges into opportunities and ensuring your product’s quality, efficacy, and safety stand the test of time.
CERES Regulatory Services
Market Insight
- Analytical methods development and validation consultation
- Regulatory specification development
- Stability study design
- Physicochemical characterization and structure elucidation consultation
- Process evaluation
- Vendor qualification programs
- Development of technical transfer packages (manufacturing and analytical methods)
- Drug Master Files (DMFs)
- CMC sections of global regulatory submissions
- Global regulatory submissions (EDMF, CDMF, IND, NDS, Certificate of Suitability)
- Post-approval support and guidance (Annual Reports, PAS, CBE, Type I and II variations)
CERES Regulatory Services
Formulation Development
- Preformulation study design
- Formulation optimization
- Manufacturing process development and optimization
- Development report preparation
- Process validation design and report preparation
- Contract Manufacturing, Packaging, and Testing
CERES Regulatory Services
CMC Updates
Data generated during the development of a drug substance, drug intermediate or drug product on the chemistry (identification, characterisation, development) manufacturing (process flow, process description), and quality controls (specifications, test methods, stability) form the Chemistry, Manufacturing and Controls (CMC) component of the regulatory submission. Note that such details may form a component of any of the following submissions: IND, NDA, ANDA or DMF. The CMC section of a dossier provides evidence of the controls put in place to assure the quality of the product be it a drug substance, intermediate or drug product. FDA current thinking is that quality should be built into the product, and testing alone cannot be relied on to ensure product quality. As such, FDA inspections a more process and system, than product focused.
CERES Regulatory Services
CMC Updates
Details provided in the CMC section of a dossier are broadly divided into the following areas for Drug Substance:
- S.1 General Information: Nomenclature, Structure, General Properties
- S.2 Manufacture
- S.3 Characterization
- S.4 Control of the Drug Substance
- S.5 Reference Standards
- S.6 Container Closure System
- S.7 Stability
CERES Regulatory Services
CMC Updates
Details provided in the CMC section of a dossier are broadly divided into the following areas for Drug Product:
- P.1 Description and Composition
- P.2 Pharmaceutical Development
- P.3 Manufacture
- P.4 Control of Excipients
- P.5 Control of the Drug Product
- P.6 Reference Standards
- P.7 Container Closure Systems
- P.8 Stability
Quick Support
Get in Touch Today!
Proactively deliver seamless core competencies with scalable. Completely fabricate transparent paradigms.
Call Us
Questions about our product or pricing? Call for support
Email Us
Our support will help you Monday to Saturday