Premier Consulting’s regulatory affairs and technical services experts have managed numerous product development and manufacturing programs for small molecules and biologics, which have culminated in the successful submission of CMC dossiers for investigational new drugs, clinical trial applications, biologics license applications, and new drug applications.
Recognizing that early involvement in product development can save you significant time and money, we advise on formulation and design, handle site inspection and monitoring, design and review protocols, and identify the best method validation strategy to ensure compliance with FDA and ICH guidelines. Our network of contract manufacturing organizations allows us to identify the most suitable service providers for your compound and dosage form, ensuring optimal performance within time and budget parameters.
CMC components include:
Drug product development: Including API and excipient sourcing, analytical development, formulation development, and report documentation
Clinical trial material: Manufacturing planning and oversight, packaging and labeling oversight, and management of inventory and distribution logistics
Supply-chain and manufacturing strategy: Oversight of technology transfers, vendor and facility selection, manufacturing strategy and process development, and process optimization
Quality and compliance: Including gap and risk assessments, technical and process auditing, process optimization and validation, and quality management system development
CMC regulatory, technical, and document review: Supporting you at all stages of drug development