Our Service
Toxicology Services
Descriptions
At Globaxa, our expert toxicology and regulatory team provides comprehensive services that ensure the safety, quality, and compliance of pharmaceuticals, biologics, and medical devices.
Combining scientific precision, regulatory insight, and advanced in-silico tools, we help you mitigate risks and accelerate approvals.
Our commitment to scientific integrity, global compliance, and ethical excellence makes us your ideal partner for safe and successful product development.
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What We Do
Occupational Safety & Risk Management
Cleaning Validation: Establishing PDE and ADE limits for APIs and cleaning agents to ensure validated cleaning protocols.
Occupational Exposure Limits (OELs): Defining safe exposure levels to protect manufacturing personnel.
Occupational Exposure Banding (OEB): Categorizing drug substances to guide effective containment and risk-management strategies.
Toxicology Risk Assessments
Impurities & Excipients: Toxicological evaluation of impurities, excipients, and cleaning agents.
Extractables & Leachables: Risk assessments for substances migrating from packaging or device materials.
Nitrosamine & TTC Studies: Specialized risk identification and TTC-based safety threshold setting.
Genotoxicity Assessment: In-silico and in-vitro evaluations using QSAR tools and ICH M7 hazard qualification.
Expert Toxicology Statements: Prepared for regulatory submissions and risk–benefit documentation.
Preclinical & Biocompatibility Studies
GLP & Non-GLP Toxicology Studies: Designed for pharmaceuticals and biologics under regulatory standards.
Efficacy & Safety Evaluation: Preclinical studies to establish therapeutic profiles.
Biocompatibility & ISO Studies: Biological evaluation of medical devices per ISO 10993/18562.
Why Choose Globaxa
Trusted globally for scientific precision, regulatory excellence, and reliable partnership in pharmaceutical development.
Globaxa provides end-to-end support for toxicology and compliance documentation aligned with ICH, OECD, and ISO standards.
Our cross-functional team of experts ensures that every assessment meets the highest levels of scientific and regulatory scrutiny.
We have experience supporting clients across the US, EU, and APAC, enabling seamless global submissions.
Our responsive support team ensures quick turnaround times and continuous client communication throughout your project lifecycle.
