CDMO/CMC Consulting (Drug Development)
CDMO Consulting
A Contract Development and Manufacturing Organization (CDMO) offers comprehensive services to pharmaceutical companies, from drug development through manufacturing. Our CDMO consulting services focus on:
- Drug Development Strategy
- Feasibility Studies: Assessing the technical and economic viability of drug candidates.
- Preclinical Development: Designing and overseeing preclinical studies to gather safety and efficacy data.
- Clinical Development: Planning and managing clinical trials phases I-III to ensure regulatory compliance and data integrity.
- Manufacturing Solutions
- Process Development: Optimizing drug manufacturing processes for efficiency and scalability.
- Technology Transfer: Ensuring smooth transition from development to commercial production.
- GMP Compliance: Ensuring all manufacturing practices meet Good Manufacturing Practice standards.
- Regulatory Support
- Regulatory Submissions: Assisting with the preparation and submission of regulatory documents to agencies like the FDA, EMA, and others.
- Quality Assurance: Implementing robust quality management systems to maintain compliance and product quality.
- Supply Chain Management
- Vendor Selection: Identifying and qualifying reliable suppliers and manufacturers.
- Logistics Coordination: Managing the supply chain to ensure timely delivery of materials and products.
CMC Consulting
Chemistry, Manufacturing, and Controls (CMC) consulting focuses on the technical and regulatory aspects of drug development and production. Our CMC consulting services include:
- Formulation Development
- Drug Formulation: Developing stable and effective formulations for various dosage forms (e.g., tablets, injectables).
- Excipient Selection: Identifying appropriate excipients to enhance drug stability and efficacy.
- Analytical Development
- Method Development and Validation: Creating and validating analytical methods to ensure accurate and reliable testing.
- Stability Testing: Conducting stability studies to determine the shelf life and storage conditions of drug products.
- Process Development and Optimization
- Scale-Up: Transitioning processes from the laboratory to full-scale manufacturing.
- Process Validation: Conducting validation studies to ensure processes consistently produce quality products.
- Regulatory Documentation
- CMC Sections for Regulatory Filings: Preparing comprehensive CMC documentation for IND, NDA, ANDA, and BLA submissions.
- Compliance with Regulatory Guidelines: Ensuring all CMC activities adhere to regulatory guidelines and industry standards.
- Quality Control and Assurance
- Quality Control Testing: Performing routine testing to ensure product quality.
- Quality Assurance Programs: Developing and implementing QA programs to maintain high standards of product safety and efficacy.
