AI-Powered Life Sciences Consulting

The Right Strategy,
Talent & Tech
Change Everything.

ZeniX sources and embeds the right talent within your organisation — combining senior consultants and proprietary AI across pharmacovigilance, regulatory affairs, quality & GxP, and CSV/CSA validation. We serve pharmaceutical, biotech, and medical device companies across FDA, EU/EMA, CDSCO, and Health Canada. Fully invested. Inspection-ready by design.

Pharmacovigilance & Drug Safety Regulatory Affairs Quality & GxP CSV/CSA & Validation
Talk to an Expert Our Services
10+
Years combined
experience
FDA · EU
CDSCO · HC
Four regulatory
frameworks
AI
Proprietary
PV platform
Pharmaceutical compliance and pharmacovigilance professionals
FDA · EU
CDSCO · Health Canada
Pharma · Biotech
Med Devices · Biologics
5+
Core service pillars
AI+
Proprietary PV platform
Our Story

Practitioners who built the tools — and the team — they wish had existed.

ZeniX was founded by a passionate pharmaceutical sciences professional who spent years at the intersection of drug safety, regulatory strategy, and quality systems — close enough to see where the industry was falling short, and driven enough to build something better.

The insight was simple: pharmaceutical, biotech, and medical device companies needed more than consultants who delivered reports and moved on. They needed a partner that brought the right expertise, the right technology, and the right commitment to outcomes — embedded, accountable, and built for the long run.

We built our own AI-powered pharmacovigilance platform because the pace of modern drug development demands automation that is trustworthy, validated, and fully traceable. We built our consulting practice around one principle: source the right talent, place them where it matters most, and measure success by what gets approved, audited, and defended — not just recommended.

Today ZeniX operates as a full-service life sciences consultancy spanning pharmacovigilance & drug safety, regulatory affairs, quality & GxP, CSV/CSA & validation, and our proprietary ZeniX AI PV Platform. Every engagement is led by a senior practitioner — never delegated to a junior team.

Headquartered in Princeton, New Jersey, we serve clients across the US, EU, India, and Canada — engaging FDA, EU/EMA, CDSCO, and Health Canada frameworks from a single accountable team.

Senior Talent, Sourced & Embedded

We identify and place the right specialists — PV scientists, regulatory affairs leads, quality managers, validation engineers — directly within your organisation. You get the expertise without the overhead of building a full in-house department from scratch.

Embedded Delivery, Not Just Advisory

ZeniX consultants work inside your team — sharing your deadlines, your submission pressures, and your inspection risk. We are accountable for the output, not just the recommendation. Our engagement model means one point of contact, end to end.

One Team, Four Regulatory Frameworks

Rather than managing separate regional partners, ZeniX gives you a unified team fluent in FDA (US), EU/EMA, CDSCO (India), and Health Canada — ensuring consistent strategy, documentation, and compliance posture across every market you operate in.

AI That Augments Experts — Never Replaces Them

Our proprietary AI PV platform automates the high-volume, time-intensive work — ICSR intake, narrative generation, signal flagging — while every output is reviewed, signed off, and owned by a qualified safety professional. Speed without sacrificing accountability.

Built to Withstand Scrutiny

Every deliverable ZeniX produces — from a PSUR to a validation protocol to a QMS procedure — is designed from the first draft to survive a regulatory inspection. Inspection-readiness is not a final polish. It is the standard we work to from day one.

What We Do

Integrated services across
the full product lifecycle

From IND filing through post-market surveillance — AI-accelerated, expert-validated, inspection-ready.

Proprietary SaaS · Flagship

ZeniX AI PV Platform

Our AI-native pharmacovigilance platform automates ICSR intake and triage, generates case narratives, flags signals, conducts automated literature search (ICH E2F/PRAC-compliant via EMBASE, MEDLINE & BIOSIS), and prepares aggregate report data — cutting processing time dramatically while maintaining full regulatory traceability across FDA, EU/EMA, CDSCO, and Health Canada. Built by practitioners. Accountable at every step.

ICSR Automation Signal Detection Aggregate Reports Literature Search FDA · EU · CDSCO · Health Canada
Pharmacovigilance

Pharmacovigilance & Drug Safety

  • ICSR processing & E2B(R3) to FAERS & EudraVigilance
  • Aggregate reports — PSUR, PBRER, DSUR, IND Annual
  • Signal detection & PRAC-compliant literature monitoring
  • Literature search — EMBASE, MEDLINE, BIOSIS automation
  • Named EU QPPV with deputy coverage
  • PSMF authoring, EudraVigilance/XEVMPD registration
Regulatory

Regulatory Affairs

  • IND/CTA, NDA/BLA/MAA & ANDA authoring & submission
  • CMC authoring & labeling review
  • FDA (21 CFR Part 312/314, ANDA — Part 314 Subpart C), EU/EMA, CDSCO & Health Canada
  • Lifecycle management — clinical through post-market
  • Global dossier strategy & regulatory intelligence
Quality

Quality & GxP

  • GxP audits, gap assessments & CAPA management
  • QMS buildout, SOPs & remediation programmes
  • Inspection readiness preparation & hosting
  • Supplier & vendor qualification
  • EU/UK Qualified Person (QP/RP) — GMP, GCP, GLP
CSV/CSA · Validation Engineer

CSV/CSA & Validation

  • CSV/CSA — 21 CFR Part 11, EU Annex 11, risk-based approach
  • IQ/OQ/PQ protocols & data-integrity gap remediation
  • Safety DB implementation & validation (Argus, Veeva)
  • RIM, CTMS & eTMF integration and validation
  • Compliant analytics & data strategy

Why AI + Experts Together

AI accelerates the work. Senior practitioners own the output. Our platform generates — our experts validate, certify, and submit. You get the speed of automation with the accountability regulators require.

No black boxes. No junior queues. Full traceability.

Built for inspection readiness

One partner. Five service pillars. Every regulated market.

  • ZeniX AI PV Platform — proprietary SaaS for ICSR automation, signal detection, literature search & aggregate reporting
  • Pharmacovigilance & Drug Safety — ICSR, PSUR/PBRER/DSUR, EU QPPV, PSMF, EudraVigilance, literature search
  • Regulatory Affairs — IND/CTA, NDA/BLA/MAA/ANDA, CMC, labeling, FDA, EU/EMA, CDSCO & Health Canada lifecycle management
  • Quality & GxP — audits, QMS, inspection readiness, QP/RP, GMP/GCP/GLP compliance
  • CSV/CSA & Validation — CSV/CSA, 21 CFR Part 11, Annex 11, safety database validation
Request a Readiness Assessment
Why ZeniX

Built different.
Accountable for results.

We're not a staffing agency or a software vendor. We bring the right strategy, talent, and technology — sourcing and embedding specialists directly within your organisation, invested in your outcomes from day one.

Right Talent, Sourced for You

We identify and embed senior PV, regulatory, quality, and validation specialists directly within your organisation — reducing hiring overhead while ensuring the exact expertise your programme demands.

Proprietary AI Platform

The only life sciences consultancy with its own AI-native PV SaaS — automating ICSR processing, signal detection, and aggregate reports while keeping your qualified team fully accountable.

4 Regulatory Bodies Covered

FDA (US), EU/EMA, CDSCO (India), and Health Canada — a single ZeniX team keeps your programme compliant across every jurisdiction without siloed regional partners.

FDA EU / EMA CDSCO Health Canada
8 Industry Verticals, One Partner

From pharmaceutical and biotech to medical devices, CNS/Neurology, and cell & gene therapy — ZeniX practitioners are fluent in the regulatory and operational differences across every sector, from clinical development through commercialisation.

Pharmaceutical Biotech Medical Devices CNS / Neurology
Embedded, Not Just Advisory

ZeniX consultants work inside your team — not on the outside issuing recommendations. We share your deadlines, your submission pressure, and your inspection risk. That's what accountability looks like.

Inspection-Ready by Design

Every deliverable — PSUR, IND, QMS procedure, validation protocol — is built to withstand FDA, EMA, CDSCO, and Health Canada scrutiny from the first draft, not retrofitted before the inspection visit.

24/7 Pharmacovigilance Coverage

Drug safety never sleeps — and neither do we. ZeniX provides round-the-clock PV coverage for serious and unexpected adverse event reporting, ensuring you meet 7-day and 15-day expedited reporting obligations to FDA, EU/EMA, CDSCO, and Health Canada without gaps.

Industries We Serve

Pharma, Biotech & Medical Devices — from IND through post-market

Our expert teams and AI platform serve pharmaceutical, biotech, and medical device companies — delivering regulatory compliance across FDA (US), EU/EMA, CDSCO (India), and Health Canada.

FDA EU / EMA CDSCO Health Canada
Insights

Expert perspectives across all four service pillars

Practical thinking from the team doing the work — spanning pharmacovigilance, regulatory affairs, quality & GxP, and validated systems.

AI & Pharmacovigilance
How AI is transforming ICSR processing — and what FDA and EMA expect from automated safety systems

AI-assisted pharmacovigilance is no longer theoretical — sponsors are deploying ML-based triage, natural language processing for narrative generation, and automated duplicate detection at scale. The regulatory question is not whether AI can accelerate ICSR processing (it demonstrably does), but how to document the oversight framework. FDA's voluntary ICSR automation guidance and EMA's Good Pharmacovigilance Practice modules both demand that the human practitioner remains accountable: AI surfaces the case, the qualified safety professional validates, signs off, and submits. The validation package for any AI-assisted PV tool must demonstrate that the system does not introduce new error modes, that outputs are reproducible, and that there is a clear audit trail linking every automated action to a qualified reviewer. Sponsors who treat their AI PV platform as a black box — rather than a validated, documented system — face significant inspection risk.

Regulatory Affairs
Aligning IND, CTA, and MAA submissions for a simultaneous FDA & EU development program

Global sponsors increasingly file IND with FDA and CTA with EMA in parallel — but the two frameworks differ in module structure, data-package timing, and acceptable CMC thresholds. The most efficient path is a single ICH CTD-format core dossier with market-specific addenda, rather than two independently maintained packages. Critical alignment points include INN/USAN naming, reference standard specifications, analytical method validation reports, and nonclinical package scope. FDA and EMA also diverge on paediatric obligations — a PREA requirement (FDA) has no automatic EMA equivalent, while a PIP (EMA) has no direct FDA mirror. Early regulatory intelligence at Phase I entry — not Phase III — defines how much rework is needed at NDA/BLA and MAA submission. CMC lifecycle management strategy, including post-approval change classification under FDA comparability versus EMA Type IA/IB/II variations, should be mapped before first regulatory filing.

Quality & GxP
Building an inspection-ready QMS for emerging biotech: what FDA and EMA actually look for

The most common findings at emerging biotech sponsors are not technical failures — they are QMS gaps: missing or outdated SOPs, uncontrolled CAPA cycles, supplier qualification records that don't withstand scrutiny, and training matrices that exist on paper but not in practice. FDA investigators (OAI classification) and EMA inspectors look for a quality culture, not just documentation. A lean but audit-ready QMS requires clear SOP ownership, a closed-loop CAPA process with verified effectiveness checks, a supplier qualification programme that goes beyond questionnaires to audits and technical agreements, and a training function that tracks competency rather than attendance. For EU market access, QP/RP appointment under Annex 16 and regular management review cycles are mandatory. Cell & gene therapy sponsors face additional complexity under 21 CFR Part 1271 and EU ATMP regulations — the QMS must scale from early clinical to commercial while remaining inspection-ready at every stage.

CSV/CSA · Validation
CSV/CSA for GxP-critical systems: how FDA's risk-based framework changes what your validation package must contain

FDA's 2022 Computer Software Assurance guidance replaced the prescriptive GAMP 5 approach with a risk-based framework that focuses testing effort on patient safety risk rather than software category. In practice, this means fewer low-risk scripts, more structured critical thinking documentation, and a validation strategy that scales with the actual consequence of system failure. For safety databases (Argus, Veeva Vault Safety), 21 CFR Part 11 electronic records and signatures remain fully in scope: audit trails must be system-generated, and access controls must be demonstrably enforced. EU Annex 11 adds data integrity requirements that mirror Part 11 but with explicit backup, recovery, and business continuity expectations. When migrating between safety database platforms, the migration validation package must address data mapping completeness, transformation logic, and a post-migration reconciliation protocol — regulators treat a failed migration as a data integrity event. AI-assisted tools within GxP systems require their own CSA approach, with documented testing of the AI decision logic against known outputs.

Careers

Join a senior team delivering inspection-ready PV

We work with the best in pharmacovigilance, regulatory affairs, quality, and GxP validation. Senior and delivery-focused? We want to hear from you.

Pharmacovigilance
Senior PV Specialist

Princeton, NJ  ·  Full-time / Contract

ICSR processing, aggregate report authoring (PSUR/PBRER/DSUR), literature search, and signal detection for a growing portfolio of biotech clients.

Apply Now  
CSV/CSA · Validation
Validation Engineer (CSV/CSA)

Princeton, NJ  ·  Full-time / Contract

Risk-based CSV/CSA for GxP-critical platforms — safety databases (Argus, Veeva Vault Safety), IQ/OQ/PQ protocols, 21 CFR Part 11, and EU Annex 11.

Apply Now  
Open Role
Don't see your role?

Remote / Princeton, NJ

We grow with our clients. Senior PV, regulatory affairs, quality, or validation experience? We want to hear from you.

Get in Touch  
Get in Touch

Let's talk about your compliance challenge

Tell us your pipeline, target markets, and compliance obligations — we'll reply with a right-sized proposal within one business day.

Office 5 Independence Way, Ste #225
Princeton, NJ 08540
Phone +1 (609) 467-4336
Email info@zenixlifesciences.com
LinkedIn Zenix Life Sciences LLC
Request a Proposal

All fields marked * are required.

By submitting this form you consent to Zenix Life Sciences LLC processing your data to respond to your inquiry. See our Privacy Policy for your rights under GDPR.