Expert in New Drug Development and Approval
Expert worked at the FDA for five years as a reviewer of new drugs, and has been a consultant for approximately 10 years since then, in assisting firms that develop new drugs in preparing the necessary documents to submit to the FDA. Assistance can be offered through all stages of the development process.
Expert has both industrial and government regulatory experience in meeting the requirements of good manufacturing practices that apply to manufacture of chemicals used as drug ingredients. She can offer assistance in the preparation of proper documentation in the form of drug master files or complete IND/NDA sections.
The preparation of chemistry and manufacturing data is extremely important to support the use of newly developed drugs in the early stages of investigation. Expert has worked with numerous firms in developing and presenting data that is evaluated by the FDA to determine the safety of the product for human use. This experience has covered a wide range of drugs, including simple inorganic materials, synthetic organic compounds, and recombinant DNA-produced materials.
Expert has prepared the detailed documents dealing with drug manufacturing that comprise a critical element in obtaining approval to market a new drug in the U.S. This has also included subsequent interaction and negotiation with the FDA staff to achieve agreement on mutually-acceptable standards. Her participation in the drug approval process, from within the FDA and as an industry consultant, provides a firm basis for assisting clients in planning for well-organized submissions.
Expert is experienced in the standards applied to the manufacture of drugs to assure that they comply with requirements for identity, strength, quality, and purity.
Expert may consult nationally and internationally, and is also local to the following cities: Phoenix, Arizona - Tucson, Arizona - Mesa, Arizona - Glendale, Arizona - Scottsdale, Arizona - Chandler, Arizona - Tempe, Arizona - Gilbert, Arizona - Peoria, Arizona
|Year: 1971||Degree: PhD||Subject: Physical Chemistry||Institution: University of South Carolina|
|Year: 1964||Degree: BA||Subject: Chemistry||Institution: George Washington University|
|Years: 1985 to Present||Employer: Undisclosed||Title:||Department:||Responsibilities:|
|Years: 1981 to 1985||Employer: National Toxicology Program||Title: Project Officer||Department:||Responsibilities:|
|Years: 1977 to 1981||Employer: FDA||Title: Chemist in New Drug Evaluation||Department:||Responsibilities:|
|Years: 1971 to 1975||Employer: Arapahoe Chemicals||Title: Health and Regulatory Affairs Chemist||Department:||Responsibilities:|
|Years: 1977 to 1981||Agency: Food and Drug Administration||Role: New drug review chemist||Description:|
|Years: 1981 to 1985||Agency: National Toxicology Program||Role: Project officer||Description:|