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Lawsonline™ Directory Expert Witness
Biomedical and Biomechanical Injury Analysis
H2 Helix Associates LLC
Star Valley Ranch, Wyoming
501 Walnut Drive, # 7669, 83127
Contact: Bruce C. Hemming, PH.D.
www.microbescan.com
208-520-4342
Or Toll Free
bhemming@microbeinotech.com
H2 Helix Associates LLC
501 Walnut Drive, # 7669
Star Valley Ranch, Wyoming 83127
Contact: Bruce C. Hemming, PH.D.
www.microbescan.com
208-520-4342
bhemming@microbeinotech.com
Environmental
Food & Waterborne Diseases-
Allergen Detection
Food Chemistry
Identifications
Meat Speciation/Adulteration
Microscopy
Qualitative Tests
Quantitative Tests
Toxins & Microbial Metabolites
Industrial Labs-
Air Quality Testing
Biochemistry & Lab-On-A-Chip Services
Biodegradation Analyses
Kinetic Growth & Growth Inhibition Assays
Metalworking Fluid qPCR
Microbial Genetics & Vector Construction
Microcosm Treatability
Mold or Fungal Ids
Pulsed Laser Fluorescence Detection
Quantitative Real Time PCR (qPCR)
Repetitive Sequence-based PCR (repPCR)
Microbiology
Lab Testing And Analysis
H2 Helix Associates, LLC
is your direct source for answers to all of your microbiological inquiries. We are a full-service laboratory that can provide microbial and biochemical analyses for your specific industry. Whether you are concerned about food safety or you need microbiological testing for your field, Microbe Inotech Laboratories has the expertise and advanced technologies to provide solid answers.
Information:
Air Pollution Control, Allergy, Biomedical and Biomechanical Injury Analysis, Biotechnology, Environmental, Food and Waterborne Diseases, Lab Testing and Analysis, Microbiology, Mold and Moisture, Water and Flood Damage,
H2 Helix Associates, LLC
is your direct source for answers to all of your microbiological inquiries. We are a full-service laboratory that can provide microbial and biochemical analyses for your specific industry. Whether you are concerned about food safety or you need microbiological testing for your field, Microbe Inotech Laboratories has the expertise and advanced technologies to provide solid answers.
Microbe Scan LLC
Saint Louis, Missouri
1100 Corporate Square Drive, Suite 224, 63132
Contact: Michael M. Ndengele Ph.D.
www.microbescan.com
314-645-2177
Or Toll Free
mmndengele@microbescan.com
Microbe Scan LLC
1100 Corporate Square Drive, Suite 224
Saint Louis, Missouri 63132
Contact: Michael M. Ndengele Ph.D.
www.microbescan.com
314-645-2177
mmndengele@microbescan.com
Environmental
Food & Waterborne Diseases-
Allergen Detection
Food Chemistry
Identifications
Meat Speciation/Adulteration
Microscopy
Qualitative Tests
Quantitative Tests
Toxins & Microbial Metabolites
Industrial Labs-
Air Quality Testing
Biochemistry & Lab-On-A-Chip Services
Biodegradation Analyses
Kinetic Growth & Growth Inhibition Assays
Metalworking Fluid qPCR
Microbial Genetics & Vector Construction
Microcosm Treatability
Mold or Fungal Ids
Pulsed Laser Fluorescence Detection
Quantitative Real Time PCR (qPCR)
Repetitive Sequence-based PCR (repPCR)
Microbiology
Lab Testing And Analysis
Microbe Scan LLC
is your direct source for answers to all of your microbiological inquiries. We are a full-service laboratory that can provide microbial and biochemical analyses for your specific industry. Whether you are concerned about food safety or you need microbiological testing for your field, Microbe Inotech Laboratories has the expertise and advanced technologies to provide solid answers.
Information:
Air Pollution Control, Allergy, Biomedical and Biomechanical Injury Analysis, Biotechnology, Environmental, Food and Waterborne Diseases, Lab Testing and Analysis, Microbiology, Mold and Moisture, Water and Flood Damage,
Microbe Scan LLC
is your direct source for answers to all of your microbiological inquiries. We are a full-service laboratory that can provide microbial and biochemical analyses for your specific industry. Whether you are concerned about food safety or you need microbiological testing for your field, Microbe Inotech Laboratories has the expertise and advanced technologies to provide solid answers.
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
The AquaMarine Group, Inc.
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
Chemistry and Manufacturing Controls ( CMC )
Clinical Chemistry
Biochemistry
Biologics
Biosimilar
Generics
Bioequivalence
Regulatory Compliance
Current Good Manufacturing Practices (cGMP)
Consent Decrees
Warning Letters
483’s
Pharmacology
Medical devices
Drug-device
Combination products
Quality Systems
21 CFR 3.2
21 CFR 4
21 CFR 111
21 CFR 211
21 CRF 312
21 CFR 600
21 CFR 820
US Pharmacopeia ( USP )
New Drug Application (NDA)
Abbreviated New Drug Application ( ANDA )
505(b)(2)
Drug Master File ( DMF )
510(k)
Pre-Marketing Authorization ( PMA )
Analytical Method Validation
Labeling
Standard Operating Procedure ( SOP )
FDA – Food and Drug Administration
Pharmaceutical Development
Oral dosage
parenteral
topical dosage forms
Merger and Acquisition ( M & A ) due diligence
Venture capital ( VC ) – funded start-up pharma
Patents
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
Shaw Biomedical Consulting
Cincinnati, Ohio
P.O. Box 24097, 45224
Contact: Dr. George J. Shaw
https://www.shawbiomed.com/
513-255-7905
Or Toll Free
gj.shaw@shawbiomed.com
Shaw Biomedical Consulting
P.O. Box 24097
Cincinnati, Ohio 45224
Contact: Dr. George J. Shaw
https://www.shawbiomed.com/
513-255-7905
gj.shaw@shawbiomed.com
Biomechanics
Biomedical Engineering
Accident Mechanism
Injury Causation & Severity
Injury Modeling
Image Analysis
Mechanism of Injury
Shaw Biomedical Consulting provides dedicated biomechanics and biomedical engineering consulting to attorneys, law firms, and expert witness services. Our consultants apply the fundamental principles of physics, medicine, and engineering to rigorously examine questions of injury causation, severity, and accident mechanism. Our firm is uniquely capable of addressing issues at the intersection of engineering and medicine. Our consultants are from the fields of medicine, physics and biomedical engineering. We have substantial expertise in injury modeling and image analysis. Our firm is happy to assist you with your biomechanics question.
Dr. Shaw holds a Ph.D. in Physics, an M.D., and is board-certified in Emergency Medicine. He currently practices in a level 1 trauma center, and previously served as a tenured Associate Professor of Emergency Medicine. He has authored over 80 peer-reviewed publications and abstracts in areas such as ultrasound bioeffects, and traumatic brain injury. He has been consulted by personal injury attorneys (both plaintiff and defense), federal and local law enforcement agencies, and public defenders offices in mechanism of injury investigations.
Information:
Biomechanics, Biomedical and Biomechanical Injury Analysis,
Shaw Biomedical Consulting provides dedicated biomechanics and biomedical engineering consulting to attorneys, law firms, and expert witness services. Our consultants apply the fundamental principles of physics, medicine, and engineering to rigorously examine questions of injury causation, severity, and accident mechanism. Our firm is uniquely capable of addressing issues at the intersection of engineering and medicine. Our consultants are from the fields of medicine, physics and biomedical engineering. We have substantial expertise in injury modeling and image analysis. Our firm is happy to assist you with your biomechanics question.
Dr. Shaw holds a Ph.D. in Physics, an M.D., and is board-certified in Emergency Medicine. He currently practices in a level 1 trauma center, and previously served as a tenured Associate Professor of Emergency Medicine. He has authored over 80 peer-reviewed publications and abstracts in areas such as ultrasound bioeffects, and traumatic brain injury. He has been consulted by personal injury attorneys (both plaintiff and defense), federal and local law enforcement agencies, and public defenders offices in mechanism of injury investigations.
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