Regulatory Affairs
Strategy & submissions (IND/CTA, NDA/BLA/MAA), CMC authoring, labeling & advertising review, lifecycle management.
Your Life-Sciences Partner
Regulatory, Quality, PV, CSV & IT Compliance
Partner with ZeniX to move faster
Maintain GxP compliance with confidence
+
Expertise Team
+
Years of Experience
/7
MI Coverage
About ZeniX Life Sciences
ZeniX is a next‑generation life‑sciences services partner blending scientific expertise with digital innovation. We help Pharma, Biotech, and MedTech organizations accelerate approvals, achieve inspection‑readiness, and operate compliant systems across the full product lifecycle.
Headquartered in New Jersey with an emerging delivery center, we combine global coverage with cost‑effective execution and a hands‑on training ecosystem to close the industry skill gap.
Regulatory Affairs
Strategy & submissions (IND/CTA, NDA/BLA/ANDA/MAA), CMC authoring, labeling/SPL, eCTD publishing.
Quality & GxP
QMS buildout, GLP/GMP/GCP audits, inspection readiness & hosting, deviations management, CAPA/change control, vendor oversight.
Pharmacovigilance
ICSR processing, signal detection, aggregate reports (PBRER/DSUR/PSUR), RMP/REMS, PV system setup.
CSV & IT Compliance
21 CFR Part 11 / Annex 11, risk‑based validation (CSV), IQ/OQ/PQ, data integrity by design.
Training & Workforce
ZeniX Academy—project‑based learning and staffing pathways for RA/QA/PV roles.
Global Delivery
US/EU client leadership for 24/7 coverage and right‑sized pricing.
What We Do
Integrated services across the product lifecycle — aligned to global regulations and GxP expectations.
Quality & GxP
GxP audits, CSV/CSA, QMS buildout, inspection readiness & hosting, vendor qualification, EU/UK QP/RP support.
Pharmacovigilance
Case processing, signal detection, aggregate reports (PBRER/PSUR/DSUR), RMP/REMS, PV system setup & governance.
CSV & IT Compliance
Validated platforms, RIM/CTMS/eTMF integrations, compliant analytics, and data strategy to accelerate decisions.
Industries We Serve
Our teams support sponsors and manufacturers across phases and modalities.
Pharma
Biotech
Medical Devices
Quality & GxP
cGxP frameworks with risk‑based validation and inspection‑ready delivery
- CSV and data integrity by design
- Mock inspections, CAPA governance, vendor oversight
- EU Qualified Person (QP) / UK Responsible Person (RP) support
Insights
Perspectives on regulatory pathways, inspection trends, and PV/MI operations.
IND/CTA to First‑in‑Human: A Practical Checklist
Key artifacts, study start‑up dependencies, and common pitfalls to avoid.
CSV: Making Validation Risk‑Based
Shifting from documents to critical thinking while staying inspection‑ready.
Scaling 24/7 Medical Information
Global MI operations that integrate safety and quality signals.
Contact ZeniX
Tell us about your program — we'll reply with a right‑sized proposal.