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BioTechLogic is a CMC consulting firm that provides technical, CMC regulatory and quality support to help clients optimize their biopharmaceutical development programs, ensuring they are efficient, compliant, and successful. Furthermore, BioTechLogic prepares and evaluates phase-appropriate quality management systems to support our client’s next stage of development. We have 20+ years of experience in recombininant protein and oligonucleotidie projects. For the last 10 years, our firm has supported over 50 gene and cell therapy products, including AAV-based projects (see attached pdf for our detailed project list).

BioTechLogic provides CMC support such as:
• IND or NDA/BLA writing
• Process validation technical writing – Stage 1, 2 and 3
• Comparability protocols
• CMC briefing book preparation
• Audit support
• Establishment and implementation of Phase appropriate QMS
• FDA inspection readiness support
• Quality system remediation
• Analytical trouble shooting
• Other applicable support

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