Request Expert

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.