Every member of our team has more than 20 years experience in the Pharmaceutical Industry. The QOS Bio team includes senior consultants that cover Clinical Development, Regulatory Strategy, CMC Regulatory, Quality Systems Development and GMP / Facility readiness. Not only do we have a seasoned team prepared to support your next project, through years in the industry we have maintained connections with colleagues in similar organizations and can help you identify consultants in additional areas - CMC Person-in-plant during critical tech transfer processing, medical writing, non-clinical project design and analysis
More than 20 years experience in Quality and Regulatory experience with GMP manufacturing of biologics and cell therapy products, including primary hepatocytes and individualized immunotherapy for oncology and infectious diseases.
Ms. Terry has prepared CMC regulatory documents for FDA, Health Canada, EMA and MHRA across multiple divisions for emerging technologies, as well as drafted CMC questions and background information for briefing documents to support Agency meetings.
Additionally Ms. Terry has been the Quality Project Manager for multiple site expansions and renovations, leading the effort to a qualified and fully GMP facilities. These facilities were determined to be GMP compliant by EMA and Health Canada. She has successfully completed technical transfers between Quality Control labs both internal company transfers and with external contract labs.
The senior consultant has more than 25 years experience in Clinical Development and Regulatory Affairs that extends across academia, small biotech and large pharma, as an in-house SME and the project consultant through global CROs.
Broad experience includes both biologics and small molecules, including new chemical entities (NCEs) and 505 (b)(2) regulatory pathway. Additionally he has led and participated in numerous FDA Pre-IND, Type A, B, C EOP2 and Pre-NSA meetings across may divisions of the FDA.
His accomplishments include the approval of one-daily lamivudine, once-daily abacavir, once-daily abacavir / lamivudine combination, and ocriplasmin.
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