Cell & Gene Therapy Experts
Cell & Gene Therapy Experts
Specializing in CMC, Analytical Development, Quality Control and Quality Assurance for Advanced Cell & Gene Therapies, providing support for all product lifecycles from pre-clinical stages to commercialization.
Empowering Industry
Our mission is to empower innovators in the cell and gene therapy space by delivering tailored, strategic solutions that bridge science and regulatory requirements. With a deep understanding of the challenges facing this rapidly evolving field, we partner with our clients to navigate complex regulatory processes, ensuring robust analytical strategies, compliance excellence, and operational efficiency. Whether you’re in the early stages of product development or scaling for commercialization, we are committed to providing the expertise and guidance necessary to accelerate your path to success.
Services
Design, optimization, qualification and validation of Analytical QC Methods for Cell & Gene Therapies, Plasmids, RNA, Peptides and small molecules.
Guidance on Chemistry, Manufacturing, and Controls (CMC) throughout pre-clinical to commercial stages.
Establishment of robust ISO-9001 compliant Quality Assurance frameworks to ensure compliance
Comprehensive, phase-appropriate Quality Control strategies tailored to your program needs.
MidOhio Quality Consulting 