Life Sciences

Potent Compound Safety Certification

A groundbreaking tool for drug innovators and contract manufacturing organizations.

Trinity Consultants’ SafeBridge group offers the SafeBridge® Potent Compound Safety Certification to contract development and manufacturing organizations (CDMOs) to assess their capabilities to safely handle potent active pharmaceutical ingredients (APIs). Our systematic approach provides an effective framework to protect worker health.

The SafeBridge® Potent Compound Safety Certification provides an objective and scientifically supportable assessment of a company's ability to safely handle and manufacture potent compounds to industry standards. To receive this certification, a company must meet minimum criteria in the management, evaluation, containment and control, and communication elements of potent compound safety. Well-defined criteria and the program scoring regimen are shared with the client in advance.

This comprehensive certification program includes an onsite assessment of both physical plant and equipment items (such as air pressure relationships, containment, and process technology), and program items such as process safety, training, medical surveillance, industrial hygiene, toxicology, and environmental controls.

Provided that the client meets the minimum criteria in each major assessment area, a letter of certification is issued, signed by board-certified professionals. Our clients use the SafeBridge® Potent Compound Safety Certification for internal assessment of programs and as a powerful marketing tool to attract new business for third party manufacturing.

Potent Compound Safety Triangle®

Trinity Consultants’ SafeBridge is known throughout the industry for the Potent Compound Safety Triangle® of services: Toxicology, Industrial Hygiene and Industrial Hygiene Analytical Chemistry. Our specific expertise is in the recognition, evaluation, and control of potential worker exposure and product safety issues associated with the handling of potent and highly potent drug substances and drug products.

How Else We Can Help

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Toxicology Services

Broad toxicological support around occupational exposure and product safety in the life science research and manufacturing environment.

Industrial Hygiene

Extensive industrial hygiene support for the life sciences sector.

Industrial Hygiene Analytical Laboratory

AIHA-Accredited Analytical Laboratory for Method Development and Sample Analysis

Hazard Communications and GHS Services

Expertise in chemical hazard classification, preparation of SDSs, and compliance with global hazard communication regulations.

Our Results

Featured Projects

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Trinity's SafeBridge Group Identifies Chloracne Source in Research Lab

SafeBridge investigated an outbreak of chloracne in a discovery lab at a top 5 pharma company, determined the novel compound responsible for the outbreak and recommended a safe course of remediation.

Pharmaceutical Leader Evaluates Safety and Quality of New Transdermal Patch

SafeBridge partnered with a global pharma company to design and perform extractables and leachables (E&L) testing and provide toxicological assessment of the results to assess the product’s safety and quality. 

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