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Robert J. Wolters, Ph.D.
Senior Consultant, Mediquest Associates, Inc.
18645 Hedgegrove Terrace
Olney, MD 20832
Phone: 301 774 3399
Fax: 301 774 4060
mediquestassociates@earthlink.net
- Over 26 years with the FDA as a reviewer of ANDAs, INDs, NDAs
and supplements.
- Last 14 years as the supervisory chemist/team leader in
Cardio-Renal Drug Products.
- 8 years as a consultant to the pharmaceutical industry.
- Primary reviewer of over 75 NDAs.
- Secondary reviewer of every NDA submitted to Cardio-Renal for
14 years, over 200 NDAs and over 1,000 supplements.
- Chaired the New Drug Substance Guideline committee and wrote
the first draft.
- Co-chaired the ICH Photostability committee.
- Served on 8 committees.
- FDA representative to the USAN Council.
- Made over 25 presentations before various pharmaceutical
groups.
- Consulted on 15 NDAs, over 15 INDs, over 25 supplements, 1
IMPD.
- Write CMC sections for INDs and NDAs.
- Consulting fees $200.00 per hour plus travel expenses with
traveling fee of $100.00 per hour.
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