Services Occupational Toxicology and Pharmacology Services

Meeting your Occupational Toxicology and Pharmacology Needs

Affygility Solutions provides a wide variety of occupational toxicology and pharmacology services to the life science industry. Since 2002, Affygility Solutions has been providing occupational toxicology and pharmacology services around the world with a team of industry professionals. We have performed these services for small to large life science companies.

Affygility Solutions offers high-quality work at competitive rates, and we provide rapid turnaround. Contact Affygility Solutions today to find out how we can meet your toxicology active pharmaceutical ingredient, excipient and chemical needs.

Potent Compound Safety Categorization and Occupational Exposure Limits

Utilizing a variety of primary and secondary literature sources, Affygility Solutions can classify (or categorize) your compounds into either your company's internal control banding scheme, or into widely accepted 4 or 5 control band schemes. For compounds in later development stages, the occupational toxicology professionals at Affygility Solutions can develop an occupational exposure limit (OEL), ADE (PDE). All documentation for each compound is provided in an easy-to-understand monograph. Our OEL/ADE monographs have been widely accepted by EMA, PIC/S, and ANVISA. If your company is just starting to establish its own potent compound safety program, the occupational toxicology professionals can help you get started in the right direction.

Excipient level, decomposition contaminates, and residual solvent level justifications

Processing and formulation of pharmaceutical products typically involves the use of excipients and solvents. In some cases, the concentration or levels of these excipients, decomposition contaminates, and residual solvents must be justified and documented. Regulatory agencies, such as the United States Food and Drug Administration (FDA) and World Health Organization (WHO), require that the level of these substances above the recommended guidelines be scientifically justified and supported. Affygility Solutions' toxicologist can perform the appropriate literature review and prepare the supporting documentation.

Reproductive Hazard Evaluations

Affygility Solutions can conduct a detailed review of the potential reproductive hazards in the workplace and provide the client with a detailed report discussing these potential hazards and any recommended steps to minimize potential adverse effects. We have performed these reviews in both laboratories and pharmaceutical manufacturing environments.

Affygility also provides risk assessments virtually. Risk assessments for potent compound safety handling and design review are critical for laboratories, pilot plants, manufacturing plants, and packaging and labeling facilities. Virtual risk assessments (VRA) are the application of modern technology tools to gather information needed to identify and evaluate the risk of employee exposures or cross-contamination when in-person methods are not possible or desired. The core process of the review remains the same regardless if it’s conducted in-person or virtually, but conducting a review virtually can save time and money. The Affygility team is experienced at navigating the nuances of a virtual review.

The expert toxicologists at Affygility Solutions are available to assist you with all your health-based exposure limit (HBEL) needs (also known as acceptable daily exposure (ADE) limits or permitted daily exposure (PDE) limits. Contact us today about our occupational toxicology and pharmacology services.

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Contact us for further information on our toxicology services.