Audits, asessments and more

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

Virtual Risk Assessment

Risk assessments for potent compound safety handling and design review that are conducted virtually. Video conferencing tools are utilized in virtual risk assessments for laboratories, pilot plants, manufacturing plants, and packaging and labeling facilities. The Affygility team is experienced at navigating the nuances of a virtual review. Virtual assessments can save time and money.

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PDE Reports by Pharma Industry Experts

PDE reports authored by DABT and ERT certified toxicologists. Comply with EMA, PIC/s, ANVISA, and WHO requirements.

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Technical Expert Assessment for the Determination of HBEL

Need a technical expert assessment for your toxicology contractor to meet EMA requirements? Affygility Solutions can prepare OEL, ADE, PDE, or HBEL monographs for all your pharmaceutical manufacturing facilities.

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Safety Data Sheets

We provide SDS authoring/writing services for both small and large biotechnology and pharmaceutical companies, and have created hundreds of safety data sheets for discovery compounds, active pharmaceutical ingredients, and finished products.

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International Potent Compound Safety Program Gap Assessment

The potent compound safety experts at Affygility Solutions understands that your business is becoming more global each day, and Affygility Solutions is here to assist your company no matter where you are located in the world.

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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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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.