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Accredited Psychiatry & Medicine Medical & Psychiatric Experts
Cambridge, Massachusetts
96 Larchwood Drive, 02138


Contact:  Harold J. Bursztajn, MD
www.forensic-psych.com
617-492-8366 Or Toll Free
harold_bursztajn@hms.harvard.edu
Medical & Psychiatric Experts
96 Larchwood Drive
Cambridge, Massachusetts 02138

Contact:  Harold J. Bursztajn, MD
www.forensic-psych.com
617-492-8366
harold_bursztajn@hms.harvard.edu
Dr. Bursztajn, MD continues to have an active clinical practice and consults as a forensic psychiatric expert and teaches nationally both as an individual and as a distinguished multispecialty team expert. He has had a long standing special interest in medical and psychiatric diagnosis. His publications analyzing clinical and forensic neuropsychiatric diagnosis and misdiagnosis range from the highly acclaimed book Medical Choices, Medical Chances through Analysis: DSM Biases Evident in Clinical Training and Courtroom Testimony published in the September 2007 issue of Psychiatric Annals.
Information:  
Forensic Psychiatry,  Forensic Psychology,  Medical Devices,  Medical Malpractice,  Neuropsychiatry,  Neuropsychology,  Pharmaceuticals,  Pharmacology,  Post Traumatic Stress,  Product Liability,  Psychiatric Medicine,  Psychiatry,  Psychological Autopsy,  Psychopharmacology,  Standard Practice (Suicide),  Suicide, 


Dr. Bursztajn, MD continues to have an active clinical practice and consults as a forensic psychiatric expert and teaches nationally both as an individual and as a distinguished multispecialty team expert. He has had a long standing special interest in medical and psychiatric diagnosis. His publications analyzing clinical and forensic neuropsychiatric diagnosis and misdiagnosis range from the highly acclaimed book Medical Choices, Medical Chances through Analysis: DSM Biases Evident in Clinical Training and Courtroom Testimony published in the September 2007 issue of Psychiatric Annals.

Avomeen Analytical Services
Ann Arbor, Michigan
4840 Venture Drive, 48108


Contact: 
www.avomeen.com
800-930-5450 Or Toll Free
scientist@avomeen.com
4840 Venture Drive
Ann Arbor, Michigan 48108

Contact: 
www.avomeen.com
800-930-5450
scientist@avomeen.com
Avomeen is a FDA-Registered, DEA-Licensed, and cGMP-Compliant Analytical Testing Laboratory. We provide expert witness, consulting, and testing services for a variety of industries. We have in court experience and are skilled at properly explaining complex findings and results in a court room setting.
Information:  
Chemicals,  Failure Analysis,  Lab Testing and Analysis,  Patents,  Pharmaceuticals, 


Avomeen is a FDA-Registered, DEA-Licensed, and cGMP-Compliant Analytical Testing Laboratory. We provide expert witness, consulting, and testing services for a variety of industries. We have in court experience and are skilled at properly explaining complex findings and results in a court room setting.

Dr. James C. Norris
Benton, Arkansas
6106 Worth Avenue, 72019


Contact:  James C. Norris
www.norrisconsultingservices.com
866-526-6774 Or Toll Free
norristoxicL@earthlink.net
6106 Worth Avenue
Benton, Arkansas 72019

Contact:  James C. Norris
www.norrisconsultingservices.com
866-526-6774
norristoxicL@earthlink.net
Dr. Norris has training in both pharmacology and toxicology and has been practicing toxicology for over 20 years. He is a recognized expert witness in pharmacology and toxicology for deposition and trial testimonies (Civil, Criminal, and Military courts; Plaintiff and Defense) in the United States, the United Kingdom and Hong Kong. He has provided testimony to governmental agencies, served as an industrial site crisis team member, and acted as a consultant to media (BBC). Dr. Norris' employment titles have included: Assistant Vice President of Toxicology & Carcinogenesis and Head of Inhalation Toxicology. He is a diplomate of the American Board of Toxicology and an EU Registered Toxicologist.
Information:  
Pharmaceuticals,  Pharmacology,  Toxic Exposures,  Toxic Tort,  Toxicology, 


Dr. Norris has training in both pharmacology and toxicology and has been practicing toxicology for over 20 years. He is a recognized expert witness in pharmacology and toxicology for deposition and trial testimonies (Civil, Criminal, and Military courts; Plaintiff and Defense) in the United States, the United Kingdom and Hong Kong. He has provided testimony to governmental agencies, served as an industrial site crisis team member, and acted as a consultant to media (BBC). Dr. Norris' employment titles have included: Assistant Vice President of Toxicology & Carcinogenesis and Head of Inhalation Toxicology. He is a diplomate of the American Board of Toxicology and an EU Registered Toxicologist.

Advantage Analytical, LLC
Marietta, Georgia
825 Chance Road, 30066


Contact:  Jon M. Crate
www.FAImaterialstesting.com
770-928-1930 Or Toll Free
info@FAI.US
825 Chance Road
Marietta, Georgia 30066

Contact:  Jon M. Crate
www.FAImaterialstesting.com
770-928-1930
info@FAI.US
Information:  
Chemicals,  Failure Analysis,  Lab Testing and Analysis,  Materials Science,  Pharmaceuticals,  Plastics, 



Susan A. Rice and Associates, Inc.
Grass Valley, California
19816 Buck Ridge Road, 95949


Contact:  Dr. Susan A. Rice, PhD, DABT
http://www.sara-tox.com/
530-346-9612 Or Toll Free
susan.rice@sara-tox.com
19816 Buck Ridge Road
Grass Valley, California 95949

Contact:  Dr. Susan A. Rice, PhD, DABT
http://www.sara-tox.com/
530-346-9612
susan.rice@sara-tox.com
Dr. Susan A Rice has been consulting and providing expert witness services in pharmacology and toxicology for over 25 years. Dr. Rice received her PhD in Comparative Pharmacology and Toxicology from the University of California, Davis and is a Diplomate of the American Board of Toxicology. Dr. Rice researches and provides expert testimony for a broad range of products, exposures, and settings. Working with attorneys, Dr. Rice can determine if claims are likely to have resulted from alleged agents or events. She helps her clients determine if claims are scientifically and medically reasonable and to develop scientifically defensible legal strategies.
Information:  
Medical Devices,  Pharmaceuticals,  Pharmacology,  Toxic Exposures,  Toxic Tort,  Toxicology, 


Dr. Susan A Rice has been consulting and providing expert witness services in pharmacology and toxicology for over 25 years. Dr. Rice received her PhD in Comparative Pharmacology and Toxicology from the University of California, Davis and is a Diplomate of the American Board of Toxicology. Dr. Rice researches and provides expert testimony for a broad range of products, exposures, and settings. Working with attorneys, Dr. Rice can determine if claims are likely to have resulted from alleged agents or events. She helps her clients determine if claims are scientifically and medically reasonable and to develop scientifically defensible legal strategies.

mdi Consultants, Inc.
Great Neck, New York
55 Northern Blvd. , 11021


Contact:  Alan Schwartz
http://www.mdiconsultants.com/
516-482-9001 Or Toll Free
alan@mdiconsultants.com
55 Northern Blvd.
Great Neck, New York 11021

Contact:  Alan Schwartz
http://www.mdiconsultants.com/
516-482-9001
alan@mdiconsultants.com
mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 37 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors. OUR APPROACH We utilize the following three part approach to providing high quality services to our clients: Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)
Information:  
Food Manufacturing,  Food Safety,  Food Service,  Medical Devices,  Pharmaceuticals,  Product Liability,  Product Warnings, 


mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 37 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors. OUR APPROACH We utilize the following three part approach to providing high quality services to our clients: Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)

Regulatory Affairs, North America, Inc.
Durham, North Carolina
Po Box 52587, 27717


Contact:  Nancy J. Chew, M.S., RAC, FRAPS
www.ranainc.com
919-949-4617 Or Toll Free
nchew@ranainc.com
Po Box 52587
Durham, North Carolina 27717

Contact:  Nancy J. Chew, M.S., RAC, FRAPS
www.ranainc.com
919-949-4617
nchew@ranainc.com
Specialty Focus: FDA regulatory requirements, Product development strategy, FDA-regulated product development, FDA regulatory liaison, regulatory submissions, clinical research applications (INDs), drug marketing applications (CTDs, NDAs), FDA approvals, US agent for FDA matters. Education: M.S. Physiology, Florida State University, 1968. B.A. Biology, Woman's College of the University of North Carolina, 1963. Years in Practice: 35+ Additional Information  Certified regulatory affairs expert with over 35 years experience in pharmaceutical regulatory affairs.  Significant teaching experience in the pharmaceutical and regulatory field, and lectures frequently on regulatory matters.  Published in technical journals, magazines, books, articles, and columns in the regulatory and pharmaceutical fields.  Member of the Scientific Advisory Board for BioLink Sciences, Inc.  Holds a regulatory affairs certification and is a fellow of the Regulatory Affairs Professionals Society (RAPS).  Co-creator of the Regulatory Affairs Professionals Society’s regulatory affairs credentialing (RAC)program.  Recipient of the Richard E. Greco Regulatory Affairs Professional Award, and the Leonard J. Stauffer Award for Mentoring, Regulatory Affairs Professional Society.  Past chair of the Regulatory Affairs Professional Society credentialing board.  Past Vice President of Education and Membership for the Regulatory Affairs Professional Society.  Past president of the North Carolina Regulatory Affairs Forum.  Fellowships Completed: o Predoctoral fellowship in Biochemistry from Cornell University Medical College. o Public Health Service predoctoral fellowship from the National Institute of General Medical Sciences at Florida State University. o Florida State University Teaching Fellowship
Information:  
Pharmaceuticals,  Pharmacology,  Pharmacy, 


Specialty Focus: FDA regulatory requirements, Product development strategy, FDA-regulated product development, FDA regulatory liaison, regulatory submissions, clinical research applications (INDs), drug marketing applications (CTDs, NDAs), FDA approvals, US agent for FDA matters. Education: M.S. Physiology, Florida State University, 1968. B.A. Biology, Woman's College of the University of North Carolina, 1963. Years in Practice: 35+ Additional Information  Certified regulatory affairs expert with over 35 years experience in pharmaceutical regulatory affairs.  Significant teaching experience in the pharmaceutical and regulatory field, and lectures frequently on regulatory matters.  Published in technical journals, magazines, books, articles, and columns in the regulatory and pharmaceutical fields.  Member of the Scientific Advisory Board for BioLink Sciences, Inc.  Holds a regulatory affairs certification and is a fellow of the Regulatory Affairs Professionals Society (RAPS).  Co-creator of the Regulatory Affairs Professionals Society’s regulatory affairs credentialing (RAC)program.  Recipient of the Richard E. Greco Regulatory Affairs Professional Award, and the Leonard J. Stauffer Award for Mentoring, Regulatory Affairs Professional Society.  Past chair of the Regulatory Affairs Professional Society credentialing board.  Past Vice President of Education and Membership for the Regulatory Affairs Professional Society.  Past president of the North Carolina Regulatory Affairs Forum.  Fellowships Completed: o Predoctoral fellowship in Biochemistry from Cornell University Medical College. o Public Health Service predoctoral fellowship from the National Institute of General Medical Sciences at Florida State University. o Florida State University Teaching Fellowship

The AquaMarine Group, Inc.
Redding, Connecticut
148 Gallows Hill Rd, 06896-1409


Contact:  Timothy A. Anderson, MS, MBA
www.aquamarinegroup.com
203-938-0378 Or Toll Free 203-241-5864
timothy.anderson@aquamarinegroup.com
148 Gallows Hill Rd
Redding, Connecticut 06896-1409

Contact:  Timothy A. Anderson, MS, MBA
www.aquamarinegroup.com
203-938-0378 Or Toll Free 203-241-5864
timothy.anderson@aquamarinegroup.com
I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 20+ years as a consultant in my own pharmaceutical development advisory firm, I have furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, to current Good Manufacturing Practice (cGMP) quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. Technical and regulatory compliance due diligence services are furnished to institutional investors. I have contributed to regulatory approvals for over 50 drug and drug/device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and have provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues. I have been deposed and functioned as a Subject Matter Expert Witness in both Federal and State jurisdictions, for class action and individual cases, and I have opined on behalf of Plaintiffs and Defendants. Main phone 203-938-0378, Cell phone 203-241-5864. LinkedIn profile www.linkedin.com/in/aquamarinegroupinc/ E-mail timothy.anderson@aquamarinegroup.com
Information:  
Biomedical and Biomechanical Injury Analysis,  Chemistry,  Labels and Warnings,  Medical Devices,  Pharmaceuticals, 


I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 20+ years as a consultant in my own pharmaceutical development advisory firm, I have furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, to current Good Manufacturing Practice (cGMP) quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. Technical and regulatory compliance due diligence services are furnished to institutional investors. I have contributed to regulatory approvals for over 50 drug and drug/device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and have provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues. I have been deposed and functioned as a Subject Matter Expert Witness in both Federal and State jurisdictions, for class action and individual cases, and I have opined on behalf of Plaintiffs and Defendants. Main phone 203-938-0378, Cell phone 203-241-5864. LinkedIn profile www.linkedin.com/in/aquamarinegroupinc/ E-mail timothy.anderson@aquamarinegroup.com

Ted Simon LLC
Winston, Georgia
4184 Johnston Road, 30187


Contact:  Ted Simon
http://www.tedsimon-toxicology.com/
770-359-9807 Or Toll Free
ted@tedsimon-toxicology.com
4184 Johnston Road
Winston, Georgia 30187

Contact:  Ted Simon
http://www.tedsimon-toxicology.com/
770-359-9807
ted@tedsimon-toxicology.com

Ted W. Simon's CV

 

398776DBC&disposition=0&alloworigin=1"> Ted W. Simon's CV

Award winning toxicologist and scientist. 10+ years’ experience as a toxicologist employed by the Environmental Protection Agency (EPA). Served as EPA’s senior toxicologist in the waste management division working on risk and soil cleanup. Expertise in toxicology, risk assessment, mathematical modeling, statistics, neuroscience, and environmental/ecological health issues. Extensive national and international public speaking experience. 15+ years teaching experience. Well published, including author of textbook on toxicology and environmental risk assessment. Experienced expert witness on issues including environmental risk, drug and alcohol cases, DUI, accidental poisoning, and intellectual property. 10+ years consulting experience. Special interest and expertise in dioxin-like chemicals and polychlorinated biphenyls (PCBs).
Information:  
DUI and OWI,  Environmental,  Pharmaceuticals,  Toxicology, 


Ted W. Simon's CV

 

398776DBC&disposition=0&alloworigin=1"> Ted W. Simon's CV

Award winning toxicologist and scientist. 10+ years’ experience as a toxicologist employed by the Environmental Protection Agency (EPA). Served as EPA’s senior toxicologist in the waste management division working on risk and soil cleanup. Expertise in toxicology, risk assessment, mathematical modeling, statistics, neuroscience, and environmental/ecological health issues. Extensive national and international public speaking experience. 15+ years teaching experience. Well published, including author of textbook on toxicology and environmental risk assessment. Experienced expert witness on issues including environmental risk, drug and alcohol cases, DUI, accidental poisoning, and intellectual property. 10+ years consulting experience. Special interest and expertise in dioxin-like chemicals and polychlorinated biphenyls (PCBs).

James J. Farley dba Cardinal Consulting & Training
Savannah, Georgia
101 Captain Johns Drive, 31410


Contact:  James J. Farley (Jim)
www.cardinalpharmaconsult.com
912-898-8505 Or Toll Free
jjf412@aol.com
dba Cardinal Consulting & Training
101 Captain Johns Drive
Savannah, Georgia 31410

Contact:  James J. Farley (Jim)
www.cardinalpharmaconsult.com
912-898-8505
jjf412@aol.com
James J. Farley (Jim) is a pharmaceutical chemist who has worked as a research chemist in the pharmaceutical industry, a former Director of Research for a pharmaceutical packaging component company, and former Science Branch Director of the Philadelphia District of the Food and Drug Administration. At the FDA, the Philadelphia Laboratory’s geographical area of responsibilities included Pennsylvania, Delaware, New Jersey, and other areas as needed. His lectures about the drug approval process have been popular with industry, academic, and public audiences. Jim is now a full-time expert witness/subject matter expert and consultant (dba Cardinal Consulting and Training) specializing in pharmaceutical issues including product liability, off-label promotion, failure to warn, patent infringement, breach of contract, and insurance claims. He also assists with responses to FDA Form 483s and Warning Letters.
Information:  
Pharmaceuticals, 


James J. Farley (Jim) is a pharmaceutical chemist who has worked as a research chemist in the pharmaceutical industry, a former Director of Research for a pharmaceutical packaging component company, and former Science Branch Director of the Philadelphia District of the Food and Drug Administration. At the FDA, the Philadelphia Laboratory’s geographical area of responsibilities included Pennsylvania, Delaware, New Jersey, and other areas as needed. His lectures about the drug approval process have been popular with industry, academic, and public audiences. Jim is now a full-time expert witness/subject matter expert and consultant (dba Cardinal Consulting and Training) specializing in pharmaceutical issues including product liability, off-label promotion, failure to warn, patent infringement, breach of contract, and insurance claims. He also assists with responses to FDA Form 483s and Warning Letters.

Biomedical Regulatory Consulting
Houston, Texas
9203 Hwy 6 South Suite 124 S326, 77083


9203 Hwy 6 South Suite 124 S326
Houston, Texas 77083

Dr. Bill Soller, Principal-sollerphd.com, provides expert witness services in medical malpractice and pharmaceutical liability cases relating to drug safety. He has a national reputation with thirty years of industry and academic research experience working with FDA on all aspects of drug efficacy, safety, and labeling, His expertise spans product safety, pharmacoepidemiology, effectiveness of drug labeling, regulatory science, and health policy. He has worked on numerous drug safety issues relating to drug-induced allergy (SJS, TEN, DRESS), liver toxicity, kidney failure, adrenal suppression, glaucoma, cataract and others. He has experience with depositions and jury trial testimony.
Information:  
Labels and Warnings,  Medical Devices,  Medical Malpractice,  Pharmaceuticals,  Pharmacology, 


Dr. Bill Soller, Principal-sollerphd.com, provides expert witness services in medical malpractice and pharmaceutical liability cases relating to drug safety. He has a national reputation with thirty years of industry and academic research experience working with FDA on all aspects of drug efficacy, safety, and labeling, His expertise spans product safety, pharmacoepidemiology, effectiveness of drug labeling, regulatory science, and health policy. He has worked on numerous drug safety issues relating to drug-induced allergy (SJS, TEN, DRESS), liver toxicity, kidney failure, adrenal suppression, glaucoma, cataract and others. He has experience with depositions and jury trial testimony.