Audits, asessments and more

Affygility Solutions provides a broad range of environmental, health and safety consulting services to the life science industry, including:

Genotoxic and Carcinogenic Impurity Assessments

The toxicology experts at Affygility Solutions have assisted pharmaceutical and biotechnology companies throughout the world in meeting the requirements for genotoxic and carcinogenic impurity assessments.

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Potent Compound Safety and Categorization

The industrial hygiene and toxicology professionals at Affygility Solutions can perform control banding categorization of potent compounds and active pharmaceutical ingredients, as well as development of occupational exposure limits. Placement of APIs into the appropriate control band is crucial to ensuring the safety of laboratory, pilot plant, contract manufacturer and manufacturing personnel.

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Risk-MaPP ADE Determination

Risk-based Manufacture of Pharmaceutical Products, or Risk-MaPP is an ISPE-endorsed approach to mitigating cross-product contamination. We can assist in determining ADEs for your compounds and other Risk-MaPP deliverables.

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Potent Compound Safety Program Design and Implementation

Need a comprehensive potent compound safety program? The experts at Affygility Solutions can design and implement a program that will meet your company's unique needs. We have worked with life sciences companies ranging in size from small startup biotechnology companies to large international pharmaceutical companies.

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Containment Validation and Surrogate Monitoring

Affygility Solutions has significant experience in containment evaluation of powders weighing enclosures, glove boxes, hand and flexible containment as well as other types of engineering controls.

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Environmental Health and Safety Auditing

EH&S audits are a proven tool that will enhance a company's EH&S and business performance. We conduct comprehensive audits that are tailored to your objectives.

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Exposure Assessments

We can perform occupational exposure assessments for active pharmaceutical ingredients (API), process solvents and laboratory reagents. No occupational exposure limit (OEL) for your API? No problem—the toxicology professionals at Affygility Solutions can assist your organization in determining an OEL.

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Material Safety Data Sheets

We provide MSDS Authoring/Writing services for both small and large biotechnology and pharmaceutical companies, and have created hundreds of material safety data sheets for discovery compounds, active pharmaceutical ingredients, and finished products.

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Occupational Toxicology and Pharmacology Services

Toxicology services offered include excipient level justifications, potent compound safety assessments, chemical toxicology review, occupational exposure limits for active pharmaceuticals ingredients, and much more.

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How can we help?

Contact us to find out how we can assist you in developing and managing your EHS program.