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Gradient

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Boston, Massachusetts, US

About Gradient

Gradient is an environmental and risk sciences consulting firm renowned for our specialties in Toxicology, Epidemiology, Risk Assessment, Product Safety, Contaminant Fate and Transport, Industrial Hygiene, Geographic Information Systems, and Environmental/Forensic Chemistry.


Since 1985, Gradient has employed sound science to assist national and global clients with resolving their complex environmental and human health challenges. Our Scientists are nationally recognized experts and active contributors to the advancement of knowledge for science solutions. Focusing on rigorous, high-end science and creative problem solving, our engagements are led by teams with top credentials and unparalleled client focus.

Our Services (16)


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Environmental Consulting

Price on request

Gradient's scientists are at the forefront of scientific developments in the field of Pharmaceuticals in the Environment (PIE). We have successfully applied our expertise to develop effective science-based strategies to address a variety of PIE projects. We have developed a tiered, environmental fate and effects data collection and decision framework that enables a sound assessment of potential environmental risks of existing and new drugs. We have provided scientific comments on proposed regulations, developed best practices for wastewater and biosolids management, prepared many environmental assessments to support regulatory filings in the US and Europe, evaluated EHS risks of drug manufacturing, published a number of impactful reports in the scientific literature, and

communicated PIE risks to the public and other stakeholders.


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Environmental Health and Safety Consulting

Price on request

Gradient's scientists are at the forefront of scientific developments in the field of Pharmaceuticals in the Environment (PIE).  We have successfully applied  our expertise to develop effective science-based strategies to address a variety of PIE projects. We have developed a tiered, environmental fate and effects data collection and decision framework that enables a sound assessment of potential environmental risks of existing and new drugs. We have provided scientific comments on proposed regulations, developed best practices for wastewater and biosolids management, prepared many environmental assessments to support regulatory filings in the US and Europe, evaluated EHS risks of drug manufacturing, published a number of impactful reports in the scientific literature, and 

communicated PIE risks to the public and other stakeholders.


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Regulatory Document Preparation and Submission

Price on request

Gradient scientists have conducted dozens of environmental assessments to support regulatory approval of new drugs with FDA (NDA) and EMA (MAA). Our project experience has ranged from scientific evaluations to support a categorical exclusion to conducting a full environmental assessment. These assessment have been conducted for a wide range of human drugs, including small molecules, biologics, RNAi therapeutics, endocrine active drugs, etc. We have long-standing collaborations with several CROs which allows us to identify, place, and oversee all required testing under GLP and consistent with EMA/FDA guidance.       


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IND/NDA/BLA Submission

Investigational New Drug/New Drug Application Submission
Price on request

Gradient scientists have conducted dozens of environmental assessments to support regulatory approval of new drugs with FDA (NDA) and EMA (MAA). Our project experience has ranged from scientific evaluations to support a categorical exclusion to conducting a full environmental assessment. These assessment have been conducted for a wide range of human drugs, including small molecules, biologics, RNAi therapeutics, endocrine active drugs, etc. We have long-standing collaborations with several CROs which allows us to identify, place, and oversee all required testing under GLP and consistent with EMA/FDA guidance.       


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Drug Development Consulting

Price on request

Gradient toxicologists and epidemiologists can help pharmaceutical companies at all stages of development to identify a strategy to safety assessment and regulatory approval.  When necessary, we partner with certified regulatory experts, subject matter experts, and analytical labs to provide our clients with comprehensive services and advice. Please contact us or visit our website for more information.

https://gradientcorp.com/pharmaceuticals.html

https://gradientcorp.com/epidemiology.html


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Toxicology Risk Assessment

Price on request

Science-based risk assessment is a cornerstone of Gradient's services. We support clients from many industries including pharmaceutical and medical device companies. Our fit-for-purpose toxicological risk assessments (TRAs) are lead by board-certified toxicologists. Our experiences in TRAs include active pharmaceutical ingredients (APIs), process-related impurities, extractable and leachable (E&L) compounds, product adulteration (e.g., packaging or cleaning issues), and many other. We provide our clients with science-based risk assessments and derive permissible daily exposures (PDEs) or other exposure limits that inform decision making, support regulatory applications, and help to ensure product safety. We offer our clients responsive, expert advice and services when it is needed the most. Please contact us or visit our website to learn more.

https://gradientcorp.com/pharmaceuticals.html

https://gradientcorp.com/medical-devices.html

https://gradientcorp.com/risk-sciences/




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Environmental Impact Assessment

Price on request

Gradient scientists have conducted dozens of environmental assessments to support regulatory approval of new drugs with FDA (NDA) and EMA (MAA).  Our project experience  has ranged from scientific evaluations to support a categorical exclusion to conducting a full environmental assessment.  These assessment have been conducted for a wide range of human drugs, including small molecules, biologics, RNAi therapeutics, endocrine active drugs, etc.  We have long-standing collaborations with several CROs which allows us to identify, place, and oversee all required testing under GLP and consistent with EMA/FDA guidance.       


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Drug Discovery & Development

Price on request
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Product Quality Control

Price on request

Product Contamination and Recall Evaluation


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Pharmacology & Toxicology

Price on request
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Medical Device Development

Price on request
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Extractable and Leachable Testing

Price on request
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Toxicology Consulting

Price on request
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Wearable Technology Development

Price on request
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Safety Pharmacology

Price on request
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Biopharmaceutical Development

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Joel Cohen

Senior Toxicologist
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Thomas Lewandowski

Principal / Toxicologist
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Isaac Mohar

Senior Toxicologist

FileType/PDF Created with Sketch. Adulterated Products.pdf

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FileType/PDF Created with Sketch. Dietary Supplements.pdf

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FileType/PDF Created with Sketch. Endocrine Disrupting Chemicals.pdf

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FileType/PDF Created with Sketch. Epidemiology.pdf

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FileType/PDF Created with Sketch. Exposure Assessment.pdf

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FileType/PDF Created with Sketch. Extractables and Leachables Assessment.pdf

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FileType/PDF Created with Sketch. Food Safety and Risk Assessment.pdf

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FileType/PDF Created with Sketch. Gene and Cell Therapy.pdf

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FileType/PDF Created with Sketch. GHS Hazard Assessment.pdf

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FileType/PDF Created with Sketch. Global Chemical Compliance and Product Stewardship.pdf

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FileType/PDF Created with Sketch. Green Chemistry and Product Sustainability.pdf

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FileType/PDF Created with Sketch. Nanotechnology Risks.pdf

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FileType/PDF Created with Sketch. Personal Care Product Safety.pdf

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FileType/PDF Created with Sketch. Pharmaceutical and Illicit Drug Forensics.pdf

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FileType/PDF Created with Sketch. Pharmaceuticals in the Environment.pdf

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FileType/PDF Created with Sketch. Pharmaceuticals.pdf

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