I offer Regulatory consulting services through Teisha Rowland Consulting, LLC, based on my experiences as a Chemistry, Manufacturing, and Controls (CMC) Reviewer at the FDA. Specifically, I served as a Staff Fellow and CMC Reviewer at the Office of Gene Therapy (OGT), within the Office of Therapeutic Products (OTP), at the Center for Biologics Evaluation and Research (CBER), within the FDA.
Consulting areas of specialization, and available services, for assisting in preparing CMC modules for cell and gene therapy product submissions to the FDA include:
- Scientific and Regulatory Assistance: Provide expert scientific and regulatory feedback on CMC portions of submissions
- Broad Range of Development Stage Assistance: Provide CMC assistance for a range of submission types and development stages (e.g., INTERACT, Pre-IND, and IND)
- Submission Writing and Editing: Provide writing and editing assistance for CMC portions of submission packages
- General Regulatory Advice: Navigate, answer questions, and provide interpretation of relevant Code of Federal Regulations (CFRs), FDA Draft Guidance documents, and other FDA recommendations
- Expertise in Cell & Gene Therapy Product Types: Scientific areas of expertise include regenerative medicine products, products derived or comprised of stem cells, induced pluripotent stem cells (iPSCs; 15+ years experience), organoids, differentiated cells, gene-edited and genome-modified cells, cellular cancer immunotherapies, rare disease treatments, pediatric therapies, and CAR-T and CAR-NK products. Additional experience in reviewing tissue-engineered products, device/combination products, and regenerative medicine products.
- Data Review, Analysis, and Interpretation: Performing scientific review, interpretation, and analysis of product manufacturing data
- Helping Ensure Product Success: Assisting in ensuring the quality, safety, and effectiveness of your cell and gene therapy product
Contact Teisha J. Rowland for pricing and availability.