Environmental risk, extractables, leachables, nitrosamine acceptable intake, OEL and OEB, and PDE.
Each assessment reads from named regulatory texts and returns the deliverable that goes into the dossier, anchored to ICH M7(R2), ICH Q3E, EMA HBEL, EMA Appendix 1, USP <1663>/<1664>, PQRI PODP and ECETOC TR 101.
ERA files against the EMA Rev. 1 Environmental Risk Assessment guideline; extractables and leachables against ICH Q3E, USP <1663>/<1664> and PQRI PODP; nitrosamines against ICH M7(R2) and EMA Appendix 1; OEL against ECETOC TR 101; and PDE against the EMA HBEL guideline.
Select a slab to jump to its assessment. Every output follows the framework’s prescribed structure, with a Klimisch-tiered citation annex and an unsigned QP sign-off block.
01
Identity and physicochemistry, primary studies, published thresholds, occupational limits, the regulatory framing and the literature, gathered for the substance in question.
02
When the substance lacks direct data, DeepC reasons from a close structural analogue, and says which one it chose and why.
03
Every safety factor is written out as an explicit multiplication, so the QP can re-derive the result from the arithmetic shown.
04
Every primary toxicity study is rated for reliability on the Klimisch scale, with a short narrative of how it was run and what its authors concluded.
05
The report follows the framework’s prescribed structure, with numbered references, a Klimisch annex and an unsigned QP sign-off block.
Each with the question it is asked, the stages it works through, and what it hands back.
Environmental risk assessment for human medicinal products.
EMA EMEA/CHMP/SWP/4447/00 Rev. 1In force 1 September 2024. Files in CTD Module 1.6.1
Procedure
Records ERA-0001 onwards, numbered in your organisation’s own sequence.
Written to the EMA ERA guideline (Rev. 1, in force since 1 September 2024). It works out whether the active substance poses a risk to the environment once excreted, from the Phase I screen through the Phase II studies and any refinement, with testing tailored to antibacterials, antiparasitics and endocrine-active substances, and labelling recommendations for the SmPC and patient leaflet.
What it returns
An ERA report in the structure of the EMA guideline for CTD Module 1.6.1, with a cover page, a Klimisch annex, numbered references and an unsigned QP sign-off block.
“Run an ERA on lacosamide 10 mg/mL solution for infusion.”
Container-closure stress-extraction qualification.
ICH Q3E · USP <1663> · USP <1664> · PQRI PODPAnalytical evaluation thresholds by product risk
Procedure
Records EXT-0001 onwards, numbered in your organisation’s own sequence.
Qualifies the substances found in container-closure extraction studies for parenteral, ophthalmic, inhalation and other higher-risk products, against the thresholds that apply to each. The study conditions open the report, and where direct toxicology data are missing, read-across to a named analogue fills the gap.
What it returns
A qualification report per ICH Q3E and USP <1664>: a full acceptance argument when concentrations are provided, or the thresholds alone for results still to come.
“Qualify the extractables identified in our pre-filled syringe stopper study against an IV dose.”
In-use migration safety thresholds.
ICH Q3E · USP <1664> · PQRI PODPICH M7(R2) less-than-lifetime limits
Procedure
Records LEA-0001 onwards, numbered in your organisation’s own sequence.
Derives a safety threshold for each chemical migrating from the container-closure into the product in normal use, the counterpart to the stress conditions an extractables assessment covers. It applies the less-than-lifetime limits for the treatment duration, the lower limit for sensitisers in parenteral and ophthalmic products, and the published acceptable intakes for substances of the highest concern.
What it returns
A risk assessment per ICH Q3E and PQRI PODP with Klimisch-scored toxicology: the total daily intake, the threshold and a margin of safety for each leachable.
“Assess the leachable risk for formaldehyde detected in our 12-month accelerated stability.”
Acceptable intake derivation in ng/day.
ICH M7(R2) · EMA Appendix 1 · FDA NDSRI GuidanceEMA Appendix 2 CPCA categories for novel NDSRIs
Procedure
Records NIT-0001 onwards, numbered in your organisation’s own sequence.
Written to ICH M7(R2) and the EMA and FDA nitrosamine guidance. It derives the acceptable intake from carcinogenicity data where they exist, by potency category for a novel nitrosamine drug substance-related impurity without them, or from the published limit; adjusts it for shorter treatment; and sets the specification limit and the control strategy.
What it returns
A nitrosamines risk assessment with its potency category, the acceptable intake in ng/day, and a control-strategy memo.
“We have a novel NDSRI from our secondary amine API + nitrite in excipients. Run a CPCA categorisation.”
Occupational exposure limit and OEB containment band.
ECETOC TR 101 · Sussman/Naumann/Pfister 2016ISPE Risk-MaPP · ASTM E2476 · OEB 1-5
Procedure
Records OEL-0001 onwards, numbered in your organisation’s own sequence.
Sets an occupational exposure limit from the most relevant critical effect, with every uncertainty factor justified, and turns it into a containment band with the engineering controls and respiratory protection that go with it. Genotoxic and sensitising APIs get the extra caution they need, and the result is checked against published exposure limits where they exist.
What it returns
An OEL as an airborne 8-hour TWA in µg/m³, its OEB tier (1 to 5) and the matching containment and respiratory protection, with every uncertainty factor justified.
“Set an OEL and OEB for our highly potent oncology API for tablet manufacturing operations.”
Permitted daily exposure for shared-facility cleaning.
EMA HBEL (EMA/CHMP/CVMP/SWP/169430/2012)Worked MACO examples · VICH GL18(R) veterinary parallel
Procedure
Records PDE-0001 onwards, numbered in your organisation’s own sequence.
Written to the EMA guideline on health-based exposure limits. It selects the critical effect across the studies, derives the PDE with each adjustment factor justified, and works through cleaning limits for the next product on the same equipment. Highly sensitising APIs, therapeutic macromolecules and genotoxic impurities without a threshold each get the handling the guideline sets out.
What it returns
A PDE report in the structure of the EMA guideline, with worked MACO examples for the next product on the same equipment.
“Derive a PDE for lacosamide for a shared oral-solid-dose facility.”
Research suite
Formulation, optimisation, literature review, deformulation, FTO, patent drafting, VCM process design and data analysis.
Biologics suite
Biologics research review, FTO analysis, and formulation and CMC study, for antibodies, ADCs, bispecifics, mRNA-LNP, AAV and cell therapy.
Overview
What DeepC hands back, how it shows its work, and the workspace around it: the platform overview.
From a first call to a pilot on your own programme.
A call with a formulation lead, who is in touch within a business day.
On your own programme, scoped with your team.
The AI model providers behind DeepC retain none of your content and train nothing on it.
Prefer email? info@deepceutix.com
