BioTechLogic provides hands-on or consultancy services for all aspects of CMC and biopharmaceutical development under R&D and GMP conditions for all stages of development—from preclinical to commercialization.
Essential to CMC program success, we design, optimize, and validate phase-appropriate analytical methods tailored to your product and processes. We recommend the utilization of fit-for-purpose assays and advanced statistical approaches to support the identification of your product’s critical quality attributes (CQAs).
Our consultants have a thorough command of diverse analytical techniques supporting comprehensive characterization, including functional and physicochemical assays, of your drug substance and/or drug product.
Preparation, documentation, and oversight to ensure the seamless transfer of your method to CROs, CDMOs, and other service organization partners
We support end-to-end traceability of analytical data from collection and analysis to data management for your quality system, regulatory filings, CMC submission summaries, and beyond. Additionally, we assist with SOP generation and management to ensure excellence in analytical execution.
We work with you on-site or virtually to identify, diagnose, and resolve analytical problems or inconsistencies.
We offer oversight and management of third-party laboratories during the development, qualification, validation, and transfer of analytical methods. Additionally, we can augment your team by providing ongoing supervision.
