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 Expert  712197

Expert in New Drug Development and Approval


Available for your Consulting and Expert Witness Needs

Arizona (AZ)
USA
Education Work History Career Accomplishments Consulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
Expert has extensive experience in complying with requirements of that part of the Act pertaining to drugs as implemented by the regulations of the FDA The requirements affect the development of drugs from the initial stages of screening to final market approval. Her experience specifically relates to the chemistry and manufacturing aspects, and comes from serving as an FDA reviewer and industry consultant.

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.

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Federal Food, Drug, and Cosmetic Act

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Food and Drug Administration new drug code

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bulk pharmaceutical chemical manufacturing

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investigational drug

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new drug

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Good Manufacturing Practice


Show Secondary and Basic Areas of Expertise
Localities:
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;  and Peoria, Arizona.

Often requested
with this expert:

Pharmaceutical Product Development and Good Manufacturing...
FDA Compliance, Pharmaceutical New Products, Management...
Pharmaceutical Development & Validation
Clinical Trial, Biomarker, Clinical Development, Drug...

Education:
Year   Degree   Subject   Institution  
1971   PhD   Physical Chemistry   University of South Carolina  
1964   BA   Chemistry   George Washington University  

Work History:
Years   Employer   Title  

1985 to

 

(Undisclosed Consulting Company)

 


 

1981 to 1985

 

National Toxicology Program

 

Project Officer

 

1977 to 1981

 

FDA

 

Chemist in New Drug Evaluation

 

1971 to 1975

 

Arapahoe Chemicals

 

Health and Regulatory Affairs Chemist

 

Career Accomplishments:
Associations/Societies

Expert is a member of the American Chemical Society, the American Association of Pharmaceutical Scientists, Drug Information Association, Regulatory Affairs Professionals Society, and the Parenteral Drug Association.


Government Experience:
Years   Agency   Role  
1977 to 1981   Food and Drug Administration   New drug review chemist  
1981 to 1985   National Toxicology Program   Project officer  

Consulting Services:
Recent Client Requests:
  • FDA expert for consultation to provide pre approval and post approval support to ensure approval of a NADA with a minimum of time spent in the review cycle of T-Pro.
  • FDA expert for consultation to provide pre approval and post approval support to ensure approval of a NADA with a minimum of time spent in the review cycle of T-rex.
  • Fda skin care packaging expert for consulting on fda regulations for skin care products packaging.
  • Expert in CMC FDA.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • FDA expert witness for consulting on an atypical antipsychotic..
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

 

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