Toxicological and regulatory support across the pharmaceutical product lifecycle — from hazard identification and exposure assessment through regulatory submissions and post-market pharmacovigilance.
Bringing a drug substance or product to market safely requires a clear picture of its hazards, real-world patient exposure, and the impurities it may carry — then translating that science into the documentation regulators expect. We support every step of that chain, from initial hazard identification through to post-market safety monitoring.
Our assessments align to ICH guidelines (M7, Q3A/B/C/D) and support filings to the FDA, EMA, and other national regulators, whether you need a single toxicological risk assessment or ongoing pharmacovigilance support.
Reviewing the intrinsic properties of an active ingredient, excipient, or impurity to flag carcinogenicity, mutagenicity, or reproductive toxicity.
Learn moreQuantifying dosage, frequency, duration, and route of administration to establish real-world exposure levels.
Learn moreAssembling toxicology summaries and safety assessments for IND, NDA, ANDA, or MAA filings.
Learn moreIdentifying and qualifying genotoxic, elemental, and process-related impurities against ICH-defined limits.
Learn moreCase processing, signal detection, PSURs/PBRERs, and risk management plans across the product lifecycle.
Learn moreWe start with your product, target market, and the specific gap you need addressed.
We define the specific clinical or regulatory work required — no fixed template.
Our specialists execute the scoped study against the applicable standard.
Documentation is delivered with ongoing support as your regulatory file evolves.
A scoped plan addressing your specific clinical or regulatory question.
Documentation aligned to the applicable standard or market.
Direct access to the specialist assigned to your engagement.
Flexible follow-up support as your regulatory file evolves.
Talk to our regulatory and scientific experts today.
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