PDE and OEL derivation, impurity qualification, nitrosamine risk assessment, extractables and leachables, and ISO 10993-aligned biocompatibility — the same toxicological reasoning applied across drug product, manufacturing exposure and device contact.
Drug, device, manufacturing exposure — one toxicological framework.
Drug-product impurities, manufacturing exposure limits, packaging leachables and device biocompatibility all draw on the same underlying toxicological reasoning — point of departure selection, assessment factor justification, exposure modelling and uncertainty handling. We structure pharmaceutical and device toxicology around that shared scientific foundation, applied consistently across drug, manufacturing and device contexts.
Drug, device, manufacturing exposure — the same toxicological reasoning, applied at every interface.
From early CMC development through to post-approval lifecycle — concrete points where senior pharmaceutical and device toxicology input shapes the file.
From CMC development to device biocompatibility — one toxicology team across the whole product.
Open tools from the same evidence base — transparent factors, editable inputs, citable output. Run a number now, refine it with us later.
PDE · OEL · ADE
Permitted Daily Exposure and Occupational Exposure Limit derivation per EMA Q&A and ICH Q3C — adjustment factors transparent and editable, so the rationale travels with the number.
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NDSRI · AI derivation · (Q)SAR-aware
Acceptable Intake derivation for nitrosamine impurities under the EMA NDSRI Q&A — (Q)SAR-aware, structure-specific, with read-across reasoning surfaced for the reviewer.
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Generic and biosimilar manufacturers facing nitrosamine queries or impurity qualification needs on legacy products. Innovators submitting marketing authorisation applications and needing PDEs, AIs, E&L assessment or read-across-based impurity justifications in parallel. Medical-device manufacturers preparing Biological Evaluation Reports under MDR with chemical characterisation gaps or toxicological risk assessment needs.
A pharmaceutical client identified a novel nitrosamine impurity for which CPCA default classification placed the AI at a level that triggered a regulatory query.
A novel nitrosamine impurity, a CPCA default category placing the AI at a level the EMA queried, and a marketing authorisation under active scrutiny.
Outcome. Compound-specific AI accepted in place of the default CPCA value. Regulatory query addressed with compound-specific justification. Marketing authorisation maintained without dossier revision; framework reusable across the nitrosamine portfolio.
Most pharma / device conversations start in one of these five places. If yours doesn't fit, send it through anyway — we'd rather hear the question than guess at it.
Often yes, through read-across from structurally and pharmacologically related compounds, with explicit assessment factor reasoning. Where the data are insufficient to support a defensible PDE, we say so and recommend the targeted study needed to close the gap.
Per the EMA NDSRI Q&A and ICH M7(R2). The starting point is an initial structural assessment — (Q)SAR predictions, structural alert review and expert mechanistic interpretation — to categorise the NDSRI under CPCA. Where the default categorisation is overly conservative for the specific structure and carcinogenicity data on close analogues exist, we derive a compound-specific AI by read-across with transparent uncertainty handling. Where suitable analogues do not exist, we recommend Enhanced Ames testing under EMA-FDA expectations.
Yes. Biological Evaluation Plans and Reports under ISO 10993-1, with chemical characterisation per ISO 10993-18 and toxicological risk assessment per ISO 10993-17 — integrated into MDR Annex I conformity assessment.
The starting point is the patient exposure scenario: maximum daily dose, route of administration, duration of treatment and patient population. From these, we set the AET and SCT, which together define which extractables and leachables need toxicological evaluation and which can be screened out below threshold. Study design is aligned with USP <1663> for extractables and USP <1664> for leachables, tailored to the specific packaging system, route and dose.
Yes. We review the query against the original submission, identify the toxicological reasoning under challenge, and draft a structured response — reinforcing the PDE, AI or biocompatibility argument with additional justification or data integration as needed.
Tell us the substance, the route and the deadline. We'll come back with an initial scope and a fit assessment.