Stephanie Cooke


Cooke Consulting, Inc.

Ms. Stephanie Cooke is the President/CEO of Cooke Consulting, Inc., using her 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biological/biotech products, medical devices, combination drug/device and nutraceutical firms. Her broad-based experience includes preparation of regulatory dossiers for human and animal pharmaceutical and biotech products, drug/device combination products and medical devices in all stages of development (INDs, NDAs, post-marketing supplements such as CBEs, Prior approval supplements, orphan drug submissions, 510ks, PMAs and HDEs). She has a long record of working with US and global regulatory authorities, successfully hosting many regulatory inspections conducted by FDA, ISO, Irish Medical Board (IMB) and acting as a regulatory liaison for filing of Marketing Authorizations and post-approval filings for pharmaceutical products (chemical and biological drug products) and for vaccine products, for Australia, New Zealand Canada, Japan, representing all countries in tech transfers, packaging site changes, manufacturing site changes, labeling changes, formulation changes and prepared filings. Ms. Cooke worked for Sc?ele¬ Pharma from 2005-2009, beginning in 2005 as Manager of Regulatory Affairs, and was VP of Regulatory Affairs and Quality Assurance/Validation for Sc?ele, prior to leaving in 2009 to start Cooke Consulting. She was responsible for regulatory staff at the US and Ireland facilities (including QPs), and was responsible for all INDs, NDAs, post-approval filings, regulatory strategy, Promotional Material and Advertising and was responsible for Quality Assurance, having responsibility for the many different contractors responsible for manufacturing, packaging, stability testing, release testing, product development (product design, formulation, testing, packaging, design and validation of manufacturing process), which were located worldwide. Responsible for auditing of vendors, for product release, for stability testing, for field alerts, for recalls, dealing with FDA and IMB on a number of different issues, including various issues related to regulatory filings, such as CMC issues, clinical issues, labeling changes, nomenclature committee issues, meetings/teleconferences related to INDs, NDAs and post-approval filings. She also held various senior RA, QA and validation positions at Merial, as Senior Manager of Regulatory Affairs, working on regulatory filings, site changes, and other projects for pharmaceutical and vaccine products. She also worked for Bayer (Visible Genetics) on IVD products that were used by physicians for HIV and Hepatitis C genotyping for diagnosis, and subsequent monitoring of patient plasma samples for determination of mutations in order to determine if changes in therapeutic regimen were required. She worked on chemistry complaints, troubleshooting issues with the test kits, conducted auditing, worked to improve Quality Systems, CAPA system, etc. and worked on the design file, led group to determine shipping container and performed stability testing. Ms. Cooke worked for Theragenics on Pd-103-based “seeds” for prostate cancer, worked on design teams, handled design control, established all testing for regulatory approval and all quality requirements for new and modified devices, as well as sterilization validation, and conduct of audits. She worked as part of several design teams, in order to design new devices for breast cancer and macular degeneration, with different delivery devices, established all regulatory requirements, regulatory strategy, established requirements for packaging and sterilization validation, biocompatibility testing, shelf life and stability testing, preclinical and clinical testing. Ms. Cooke worked for Cryolife and other pharmaceutical, biotech and medical device companies, after beginning in industry as a lab tech and working as a certified as a Microbiologist. establishing auditing programs to qualify contract manufacturers and vendors of raw materials, APIs, etc. and product release experience in manufacturing environments and for companies using contract manufacturers, responsibility for establishing and maintaining Quality systems for all product types (CAPA, Change Control, Complaint handling, Document Control systems), stability programs, as well as preparation/performance of process validation(s), sterilization validation(s) (EtO, steam, gamma), aseptic processing, qualification of cleanrooms/water systems and qualification of equipment. Stephanie has been involved in the development of drugs and devices, from product concept through post-approval maintenance and is experienced in the formulation or design of new drugs or devices, establishing required preclinical and clinical testing necessary, Regulatory and Quality Requirements, including requirements for submission, process validation, etc. and has considerable project management experience. Stephanie has a BS in Biology and an M.S. in Molecular Genetics and Biochemistry.
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