We help pharmaceutical, biotech, and medical device companies enter and stay in global markets — with end-to-end regulatory affairs, pharmacovigilance, and materiovigilance support.
Aligned with global regulatory frameworks
Regulatory Affairs helps you enter the market.
Pharmacovigilance helps you stay in the market.
24/7 QPPV & Deputy QPPV cover.
Senior practitioners. Real submissions.
PharmaRevix is built by professionals with deep, hands-on experience in regulatory affairs and pharmacovigilance. We help companies register products on time and keep them safely available in the market — while staying ahead of evolving regulations and safety expectations.
Consider us part of your team. We support the full lifecycle — from strategy and submissions to post-market vigilance — across the EU, US, Canada, ANZ, GCC, Switzerland, South Africa, Latam, and ROW.
Pathway identification, biowaiver and bioequivalence strategies tailored to your product and target markets.
Learn moreLeverage EU/US approvals for accelerated access to UK, GCC, APAC, and LATAM markets.
Learn moreContinuous monitoring to identify risks and opportunities and inform your compliance posture.
Learn moreNew submissions, variations, renewals, annual reports, and eCTD publishing — plus MA holding.
Learn moreEffective engagement with authorities — agenda planning, briefing books, and documentation.
Learn moreCMC, risk assessments, clinical and non-clinical overviews to current ICH guidance.
Learn moreModule 1–5 authoring, baseline conversion, eCTD publishing and validation.
Learn morePI and DMF translation, artwork preparation, mock-up review, and lifecycle management.
Learn more24/7 QPPV and Deputy QPPV cover, plus LSO and Contact Person services across regions.
Learn morePSMF authoring, safety database setup, SDEAs, data migration, and ongoing stewardship.
Learn moreSystematic global literature monitoring for ADRs and signals — FDA, EMA, ICH-aligned.
Learn moreICSR receipt, triage, processing, medical and quality review, and timely E2B submissions.
Learn morePSUR, PBRER, PADER, and ACO authoring with medical and quality review through to submission.
Learn moreEU-RMP and US-REMS authoring, updates, and mitigation strategy design.
Learn moreScheduling, detection, validation, evaluation, and QPPV safety review aligned to GVP IX.
Learn moreSOP development, GAP analysis, and audit readiness across PV and regulatory operations.
Learn moreA team of senior individuals with deep regulatory and PV experience across markets and modalities.
Scientific depth with clear, practical strategy — no template-driven deliverables.
We measure ourselves by your approvals, inspection outcomes, and continued market access.
Project-based, retainer, dedicated support, or one-time remediation — whatever fits.
Best for product-specific submissions or a defined deliverable.
Ongoing support with predictable monthly engagement and priority response.
Embedded regulatory or PV resource model for sustained programs.
Targeted help to close gaps before an inspection or audit.
"PharmaRevix gave us the regulatory clarity we needed to plan a confident EU submission — they felt like part of our team."
"Their QPPV cover and PSMF support helped us pass a regulatory inspection with no critical findings."
"From dossier compilation to artwork — fast, accurate, and always on top of regional differences."
Headquartered in India, with offices in the UK and Poland, and partner reach in the GCC and ANZ — PharmaRevix supports submissions and pharmacovigilance across the EU, US, Canada, ANZ, GCC, Switzerland, South Africa, Latam, and ROW.
Talk to a PharmaRevix specialist about your product, your timeline, and your target markets.
