eCTD Module
Status Submitted
PV Compliant
Approved
Our craft

Built around real regulatory practice.

Who We Are

A team built around real regulatory experience.

PharmaRevix Private Limited is a global regulatory affairs, pharmacovigilance, and materiovigilance consultancy. We are a team of passionate professionals with years of hands-on experience — helping pharmaceutical, biotech, and medical device companies enter and stay in global markets.

We understand evolving regulatory frameworks and emerging safety expectations, and translate them into clear strategies and execution. From early-stage development through post-marketing surveillance, we work as an extension of your team — supporting submissions, inspections, vigilance, and continued compliance.

Regulatory Affairs Pharmacovigilance Materiovigilance QMS & Audits
See what we deliver
Our Mission

Your success is how we
measure ours.

We measure our performance by your regulatory milestones, product approvals, and pharmacovigilance compliance. Compliance, for us, isn't a checklist — it's a culture.

Client-focused engagement

Built around your timelines, your constraints, and how your team prefers to work.

Regulatory excellence

Sustained market presence as the outcome — not just a one-time approval.

Pharmacovigilance compliance

Inspection-ready systems that hold up to MHRA, EMA, FDA, and ICH scrutiny.

Practical strategies

Grounded in scientific and regional expertise — solutions that actually ship.

What Sets Us Apart

A compliance partner,
not just a vendor.

Pillar 01

Strategic Expertise

A team of senior professionals with years of hands-on regulatory and pharmacovigilance experience across markets, modalities, and authorities. We bring strategy, not just execution.

Pillar 02

Tailored Approach

We combine scientific depth with practical strategy — every deliverable is shaped to your product, your stage, and your regulatory geography. No copy-paste outputs.

Pillar 03

Your Success, Our Mission

We measure our performance by your milestones. Approvals on time. Inspections passed. Products available to patients without disruption.

Pillar 04

Flexible Engagement

Project-based work for defined deliverables. Retainers for ongoing partnership. Dedicated regulatory or PV resourcing. One-time remediation. We adapt to your model.

Our Values

The principles
that guide our work.

Four values shape every engagement, every deliverable, and every decision we make. They are non-negotiable.

01

Integrity

We protect patient safety and product integrity above everything else.

02

Scientific Rigor

Decisions are grounded in evidence, guidance, and current regulatory science.

03

Partnership

We act as part of your team — accountable, responsive, and proactive.

04

Practicality

Strategies that work in the real world — within your timelines and budget.

Our Team

Senior people. Real experience.

Behind every PharmaRevix engagement is a senior practitioner accountable for outcomes — not a junior delivery layer.

Full profiles coming soon
Leadership

Founder & CEO

Profile coming soon

Senior regulatory affairs leader with multi-region submission experience.

PV Lead

Head of Pharmacovigilance

Profile coming soon

EU & UK QPPV with inspection-readiness expertise.

RA Strategy

Regulatory Strategy Director

Profile coming soon

eCTD publishing, MAA, and lifecycle management lead.

Quality

Head of QMS & Audits

Profile coming soon

SOP development, GAP analysis, and inspection readiness.

Join the team

We're always looking for senior regulatory and PV practitioners.

View Open Roles
Global Presence

One team.
Five countries. Global reach.

Offices in India, the UK, and Poland — supporting clients across the UAE, Australia, and beyond. We coordinate submissions and pharmacovigilance operations across UK, EU, MENA, APAC, and ROW markets.

India
HQ · New Delhi
United Kingdom
Harrow
Poland
Kraków
UAE · Australia
Partner presence
Explore our global presence
India HQ
UK
Poland
UAE
Australia
Office
Partner
Free 30-minute consultation

Let's talk about your
next submission.

Tell us about your product and target markets. We'll listen, ask the right questions, and tell you what's realistic.