At PharmaRevix, we deliver Regulatory Affairs support across the UK, EU, US, and global regions — ensuring compliance, quality, and faster market access. Our team works with you on strategy, technical documentation, submissions, and lifecycle management.
Discovery call to understand your product, stage, and target markets.
Map the regulatory pathway, timeline, risks, and resourcing model.
Author dossiers, compile eCTD, manage submissions and deficiency responses.
Variations, renewals, lifecycle artwork, and ongoing compliance.
From global generics manufacturers to virtual innovators — we adapt to your scale, modality, and regulatory geography.
We know what each authority wants and how to time it — UK CP differences, EU MRP nuances, FDA Type meetings.
A senior strategist on every engagement. No junior delivery without expert oversight.
Strategy through submission through lifecycle — one team, one accountable owner.
Documentation built to hold up to MHRA, EMA, and FDA scrutiny — not just to file.
Regulatory submissions alone aren't enough — pair them with safety and quality.
24/7 QPPV cover, PSMF maintenance, ICSR processing, signal management, and aggregate reports.
Explore PV servicesPost-market surveillance for devices and IVDs, FSCA/FSN coordination, MDR/IVDR compliance.
Explore MateriovigilanceSOP development, GAP analysis, internal audits, and inspection readiness across PV and regulatory operations.
Explore QMSQuick answers to what teams typically ask before engaging us. Don't see your question? Reach out directly.
Ask us anythingPharmaRevix supports submissions to MHRA (UK), EMA (EU centralized), national EU agencies via MRP/DCP, FDA (US), GCC-DR and member state authorities, TGA (Australia), CDSCO (India), and ROW markets across APAC, LATAM, and Africa.
eCTD (electronic Common Technical Document) is the standard electronic format for regulatory submissions. PharmaRevix delivers Module 1–5 authoring, baseline conversions, sequence management, and eCTD validation on modern toolchains — through to final submission.
Yes. PharmaRevix provides virtual MAH and MAH-of-record services for the UK and EU, including ongoing regulatory and PV obligations, variations, renewals, and lifecycle management — so you don't need a local legal entity to commercialize.
Most engagements start within 1–2 weeks of agreement. For urgent one-time remediation work, we can typically begin within days — particularly where the scope is well-defined.
Four models: project-based (fixed scope/price), monthly retainer (predictable ongoing engagement), dedicated embedded resourcing (full-time RA professionals working as your team), and one-time remediation (targeted sprints before audits or inspections). We'll propose the right fit on the consultation call.
Book a free 30-minute call with a senior team member to explore how we can support your regulatory goals.
