Toxicology Services

At SP Group, we’re committed to workplace health and safety and making sure you stay current with all regulations. Our toxicology services protect workers from harmful exposures in the workplace by identifying and managing risks associated with chemical, biological, and physical agents, then implementing proven solutions that keep you and your team safe and compliant. Contact us today for a consultation or to book our toxicology services.
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Why Partner with The SP Group?

At SP Group, we evaluate potential hazards, including carcinogens, mutagens, and reproductive toxins, assess how workers may come into contact with these agents, and then recommend and implement solutions so you can be 100 percent sure that your team and work environment is safe and compliant.

Excipient Level Justification

DPharmaceutical products and drug development often rely on excipients and solvents during processing and formulation.

In some cases, the concentrations of these excipients, residual solvents, or decomposition contaminants must be evaluated, justified, and documented. This is because these excipients can influence the physical state, route of administration, stability, manufacturing processes, and compatibility with active pharmaceutical ingredients (APIs).

Unexpected findings during stability studies can complicate product development. When these occur, we would provide expert support by identifying and justifying specification increases for impurities across a wide range of active pharmaceutical ingredients (APIs).

Genotoxic and Carcinogenic assessments

Pharmaceutical companies must comply with regulatory guidelines established by the FDA (Food and Drug Administration) and EMA (European Medicines Agency) to ensure the safety and efficacy of their products.

We provide services to identify potential genotoxic and carcinogenic impurities and evaluate impurities for mutagenic potential.

Potent Compound Safety

At every stage of drug development, it is important to ensure employee health and safety by limiting exposure to active pharmaceutical ingredients (APIs). From early research to manufacturing, potent compound safety services provide guidance to manage risks and
maintain health security.

Our categorization process delivers detailed reports that include:

• Occupational Exposure Limits (OELs)
• Acceptable Daily Exposure (ADE) values
• Control bands (if applicable)

Potent Compound Program Design

We offer tailored potent compound safety programs designed to fit your company’s specific needs and existing infrastructure. Our services include:

• API categorization and control banding criteria
• Risk assessments to evaluate exposure potential
• Recommendations for engineering controls and safe handling practices

Reproductive Hazards

Protecting reproductive health in the workplace is a critical component of ensuring employee well-being, especially in environments where employees may be exposed to hazardous substances. Reproductive hazards can arise from exposure to certain chemicals, biological agents, or physical stressors, which may affect fertility, pregnancy outcomes, or fetal development.

We provide services in evaluating and mitigating reproductive risks in laboratories, pharmaceutical manufacturing facilities, and other high-risk environments.

Additional EHS Services We Provide

Environmental Health & Safety

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Occupational Health & Safety

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Facility
Support

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CMC Management

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