Business Details
24 Years
experience
Your Trusted Partner for EHS Solutions in Life Sciences
Since 2002, Affygility Solutions has established itself as a leader in environmental, health, and safety (EHS) consulting for the life sciences industry. Our team of certified toxicologists and industrial hygiene professionals brings decades of hands-on experience in potent compound safety, occupational toxicology, and regulatory compliance. We serve over 800 clients across 75+ countries, delivering rapid, high-quality solutions tailored to biotechnology, pharmaceutical, and medical device companies. Our OEL Fastrac platform provides award-winning access to 2,500+ occupational exposure limit monographs, while our Affytrac software automates EHS program management. With operations in the U.S., Canada, Brazil, Singapore, and the UAE, we offer 24/7 support for global regulatory challenges.Our quality-driven process begins with DABT- and ERT-certified toxicologists who ensure compliance with EMA, PIC/S, WHO, and ANVISA standards. We pioneered virtual risk assessments using video conferencing tools, saving clients time and money while maintaining rigorous safety evaluations. Our services include safety data sheet authoring, genotoxic impurity assessments, and customized EHS training programs. Headquartered in Broomfield, Colorado, we combine local expertise with international reach to simplify complex EHS requirements. Our mission remains focused on providing simple, affordable solutions that empower life science companies to achieve high-performance safety outcomes.
Services
Occupational Toxicology
Virtual Risk Assessment
EHS Software
Safety Data Sheets
Potent Compound Safety
OEL Monographs
Containment Validation
Regulatory Compliance
EHS Training
Exposure Assessments
Details
- Year established: 2002
Highlights and features
- We offer 23+ years of specialized experience in life sciences EHS consulting
- Our team includes DABT- and ERT-certified toxicologists with pharmaceutical industry expertise
- We serve clients in 75+ countries with localized regulatory compliance solutions
- Our OEL Fastrac platform provides instant access to 2,500+ regulatory-compliant monographs
- We pioneered virtual risk assessments that save time and reduce operational costs
Services
Occupational Toxicology Services
Our certified toxicologists prepare occupational exposure limit (OEL) and permitted daily exposure (PDE) monographs for pharmaceutical compounds. We help clients meet international regulatory requirements through scientific evaluations of active pharmaceutical ingredients. Our services support drug development programs with control banding categorization and safety data sheet authoring.
Virtual Risk Assessment
We conduct virtual risk assessments for potent compound handling using video conferencing tools. This service evaluates laboratory, pilot plant, and manufacturing facilities while maintaining compliance with safety standards. Virtual assessments reduce travel costs while ensuring thorough evaluation of engineering controls and administrative practices.
EHS Compliance Software
Our Affytrac software automates environmental health and safety program management for life science companies. The web-based system helps manage regulatory requirements, safety documentation, and compliance tracking. Currently implemented at multiple biotechnology and pharmaceutical companies, it streamlines EHS operations through centralized data management.
Safety Data Sheets
We create safety data sheets for discovery compounds, active pharmaceutical ingredients, and finished products. Our services cover hazard communication requirements for both small and large life science companies. We have authored hundreds of SDS documents that comply with global regulatory standards for chemical safety information.
Potent Compound Safety
Our experts perform control banding categorization of potent compounds and active pharmaceutical ingredients. We develop occupational exposure limits and implement comprehensive safety programs tailored to client needs. This service ensures personnel safety in laboratory, pilot plant, and manufacturing environments through proper API classification.
Questions
What industries does Affygility Solutions serve?
We specialize in serving biotechnology, pharmaceutical, and medical device companies globally.
What is OEL Fastrac?
OEL Fastrac is our award-winning digital platform providing instant access to 2,500+ occupational exposure limit monographs for life science companies.
Do you offer virtual risk assessments?
Yes, we conduct virtual risk assessments using video conferencing tools for laboratories and manufacturing facilities worldwide.
Are your toxicologists certified?
Our team includes Diplomates of the American Board of Toxicology (DABT) and European Registered Toxicologists (ERT).
Do you provide international regulatory compliance support?
Yes, we help clients navigate EMA, PIC/S, WHO, and ANVISA regulations with global team support.
What EHS software solutions do you offer?
Affytrac is our secure web-based EHS management software currently used by dozens of life science companies.
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