Toxicology Risk Assessment
HBEL, PDE and ADE values, ICH M7 genotoxic impurity assessment, nitrosamine risk and device biological evaluation, signed by DABT and ERT certified toxicologists.
Nonclinical regulatory services
Submission-ready, from the first study to the final dossier.
MagenX is a Massachusetts regulatory consultancy for pharma and biotech teams. We lead the relationship for U.S. clients and deliver with our scientific partner, Auxochromofours, so your work is built by specialists who know what regulators check first.
Intelligence, Innovation, Impact
Regulatory and nonclinical
Four services that take a filing across the line.
Documents built for FDA, EMA, MHRA, PMDA, TGA and Health Canada reviewers, prepared by specialists who know what regulators check first.
SEND Services
CDISC SDTM nonclinical datasets with Define.xml, the nSDRG and Pinnacle21 validation reports, across SENDIG 3.1, DART, Animal Rule and Genetox.
Computer System Validation
GAMP 5 validation for ERP, LIMS, SCADA and GxP Excel, with full IQ, OQ and PQ documentation. 21 CFR Part 11 and EU Annex 11 compliant.
Regulatory Publishing and Submissions
eCTD and CTD dossier compilation and QC for IND, NDA, ANDA, DMF and CTA filings, plus legacy submission migration.
Our partnership
Scientific delivery by Auxochromofours, led for U.S. clients by MagenX.
MagenX partners with Auxochromofours Solutions, a scientific and regulatory services team in Bangalore, India. You get one U.S. point of contact and a specialist team behind every deliverable.
MagenX: your U.S. lead
Scoping, contracting and project coordination for U.S. clients, and a review of every deliverable before it reaches you.
Auxochromofours: scientific delivery
Toxicology risk assessment, SEND, computer system validation and regulatory publishing, delivered by the Auxochromofours team in Bangalore, India.
How we work
Tell us your next submission date. We plan backwards from it.
Work runs as a project, in milestones, on a retainer, or with an embedded specialist, whichever fits your pipeline.
1
Brief
Tell us the filing or the question, your timeline and the data you hold.
2
Scope
A short scoping call, then a written proposal within 48 hours.
3
Deliver
Milestone-based delivery with one accountable lead and clear review points.
Who we serve
- Pharma innovators and generics
- Biotech and virtual pharma
- Medical devices, Class I to III, and SaMD
- Cell and gene therapy
- CROs and GLP laboratories
- API and bulk drug manufacturers
- Cosmetics and personal care
About MagenX
Practical nonclinical regulatory support.
MagenX is a Massachusetts regulatory consultancy for pharma and biotech teams. We focus on nonclinical work: toxicology, SEND, computer system validation and submissions.
Our approach is practical, fast and honest about what the data can support.
Start a conversation
Ready when your filing is.
Send a short brief and we will return a scoped proposal within 48 hours.
Email info@magenx.bio