About

A consultancy small enough to care. Run by the people whose names go on the work.

NexGenTox is an expert-led toxicology and regulatory consultancy. We work the way good science is meant to be done — slowly, carefully, and with someone's name on every page.

The founders

Why we exist

“

Too many dossiers we'd reviewed as authority assessors were technically compliant — and quietly indefensible.

We founded NexGenTox to invert that pattern. Every engagement is owned end-to-end by a senior scientist whose judgement is on the file, whose reasoning has been stress-tested against authority objections before submission, and who walks into the regulatory meeting with you.

Junior colleagues contribute under direct senior supervision. Nothing is delegated quietly.

We take on fewer projects — and work each one as though our reputations depended on it.

Founders

The people who'll do the work.

No business-development middle layer. The founders scope, build and defend every project — and decide which ones we take on.

Sanghamitra Mishra

Founder & Managing Director

European Registered Toxicologist and Diplomate of the American Board of Toxicology with over eighteen years across regulatory toxicology, hazard characterisation and human health and environmental risk assessment — chemicals, cosmetics, biocides and pharmaceuticals.

Particular depth in endocrine disruptor assessment under EFSA/ECHA, pharmaceutical impurity work (ICH M7, nitrosamines, E&L), PDE/DNEL derivation, SCCS-aligned cosmetic safety, and the regulatory application of read-across, (Q)SAR and exposure-led NGRA.

ERTDABTEUROTOXSCCS / ECHA / EMA / EDQM engagement

Sabyasachi Patri

Co-founder · Analytical sciences, study monitoring & quality

Twenty years in pharmaceutical analytical and quality science: bioanalytical method development and validation across LC-MS/MS platforms, clinical and bioequivalence study monitoring, GxP compliance, data integrity, and regulatory inspection readiness.

Builds inspection-ready workflows around outsourced preclinical and clinical programmes — CRO qualification, audit-trail review, root-cause investigation for failed BE studies, and preparation for US FDA and equivalent inspections.

GLP / GCP / 21 CFR Part 11QMS / LIMS / ELNCRO oversightFDA inspection-ready

Subject matter experts

Specialists who join when the file calls for them.

Senior independent scientists collaborating with NexGenTox on a project basis — engaged where focused regulatory or methodological depth is required.

Dr T N Sathya

Medical device toxicology & biocompatibility

Board-certified toxicologist (DABT, ERT) with over twenty years in regulatory toxicology, specialising in biological safety evaluation of medical devices under ISO 10993 and EU MDR / FDA pathways. Experience spans catheters, sterile-barrier systems, sutures and implantable products through conformity assessment, Notified Body interactions and lifecycle support.

Collaboration: independent subject matter expert engaged by NexGenTox for medical device biocompatibility, ISO 10993 strategy and EU MDR / FDA documentation.

DABTERTISO 10993EU MDR / FDA

Dhyanesh Doshi

EU REACH regulatory toxicology & study monitoring

European Registered Toxicologist with 17+ years across EU and US regulatory frameworks — including direct work with the US EPA OPPTS on FIFRA pesticide reviews. Hands-on REACH dossier preparation in IUCLID since 2008, plus study-monitor experience across OECD 471, 476, 408, 414, 421 and 422.

Collaboration: joins NexGenTox project-by-project for REACH dossier work, IUCLID submissions and OECD study monitoring.

ERTREACH / IUCLIDFIFRAOECD study monitor

Dr Balasubramanian Ramanathan

Regulatory strategy & QMS compliance

European Registered Toxicologist with 20+ years across agrochemicals, biopesticides, industrial chemicals, medical devices, biologicals and pharmaceutical toxicology under OECD/GLP/ICH, OPPTS and OCSPP. Deep experience in biocompatibility (ISO 10993), CDSCO licensing in India, and QMS implementation — ISO 13485, ISO 9001, ISO 17025.

Collaboration: NexGenTox engages Dr Bala for medical device regulatory work (including biocompatibility) and preclinical study monitoring and audit, alongside safety and risk assessment across sectors.

ERTISO 10993 / 13485USEPA / EU MDR / CDSCOQMS & NABL

Kirsty-Jo Muddiman

Ecotoxicology, environmental fate & REACH

Twenty years across chemicals, biocides, agrochemicals and pharmaceuticals — environmental risk assessment, ecotoxicology, biodegradation and EU/UK REACH. Hands-on across the data lifecycle, from CRO-level study monitoring through registration dossiers, CSRs, exposure assessment, gap analysis and poison-centre notifications.

Collaboration: independent subject matter expert collaborating with NexGenTox on ecotoxicology, environmental fate, exposure and risk assessment under REACH, study monitoring and EU/UK regulatory compliance.

EU / UK REACHEcotox & fatePCN3Rs / adaptive testing

Elena Fioravanzo

Director, ToxNavigation · In silico & computational toxicology

Director of ToxNavigation and lead consultant / principal tutor on its training programmes. Computational chemistry, molecular modelling and (Q)SAR applied to regulatory toxicology since the implementation of REACH and the establishment of ECHA in 2007 — hazard characterisation and integration of in silico evidence into weight-of-evidence frameworks; 130+ posters and publications.

Collaboration: NexGenTox partners with ToxNavigation for specialist in silico services and regulatory training delivered through Elena's team.

(Q)SARIn silico WoEEU research projectsTraining · ToxNavigation

+ Specialist
network Engaged project-by-project

Beyond the bench

Curated independent specialists

We engage further senior independents in ecotoxicology, in silico modelling, exposure science and statistics where a project warrants — with scientific oversight retained.

Our process

How a NexGenTox project actually runs.

Six steps from the regulatory question to a deliverable structured for scrutiny. Each one is led by a senior scientist whose name is on the file.

Step 01

Start with the scientific and regulatory question.

We begin with the specific toxicological question, regulatory framework, decision context and nature of the uncertainties — not a default methodology or template.

Step 02

Evaluate the evidence base.

We assess what data exist, what weight they can carry, and where the gaps are. Where data are sufficient, we build the position directly. Where they are not, we identify the most appropriate path — targeted review, read-across, NAM-derived evidence or focused data generation.

Step 03

Transparent reasoning from the outset.

Assumptions, uncertainties and weight-of-evidence reasoning are documented as the assessment is built — not added retrospectively. Traceability is designed in, not bolted on.

Step 04

Fit-for-purpose project design.

Focused project setups with clear scope and project management, bringing in specialist collaborators only where the question demands it. No padded timelines, no consultant-hours billed against work the file doesn't need — quality without unnecessary complexity.

Step 05

Responsible use of digital tools.

Digital tools, automation and AI-enabled workflows are used selectively to improve efficiency, consistency and traceability. Scientific interpretation and decision-making remain expert-driven.

Step 06

Deliverables built for scrutiny.

Outputs are structured to anticipate the questions a regulator, evaluating authority or peer reviewer would ask — and to provide clear, defensible answers before they are raised.

Three commitments

Three commitments. The rest follows.

Underneath the process, three working rules we don't bend.

Senior-led, start to finish.

The toxicologist who scopes your project is the one who builds it, signs it, and defends it. No junior drafting under a senior's name.

The case before the document.

We start by writing the argument we'd defend at a hearing. The dossier is the structured form of that argument — not the other way around.

We say no to fit.

We turn down work outside our judgement, and we turn down work where the timeline forces shortcuts we wouldn't sign off. It costs us projects. It's what makes us worth hiring.

Scoped tightly. Priced honestly.

Fixed fees on defined deliverables. Transparent T&M only where the scope is genuinely open. Senior expertise without big-firm overhead.