PharmaRevix serves six life-sciences industries — each with distinct regulatory frameworks, safety obligations, and market access challenges. We adapt to yours.
Generics, innovators, OTC, and biosimilars — across small molecules and complex products. End-to-end regulatory and PV support for every stage of the product lifecycle.
Early-stage to commercial. We support clinical-to-commercial submissions, RMPs, and global PV systems — giving biotech teams the regulatory depth of a large pharma function without the overhead.
EU MDR / IVDR, UKCA, and global compliance — strategy, technical documentation, and post-market vigilance. PharmaRevix covers the full device lifecycle from classification through post-market surveillance.
Regulatory pathway clarity, labeling compliance, and registration support across regions. We help nutraceutical and cosmetic brands navigate complex, jurisdiction-specific requirements with confidence.
Regulatory and PV support for veterinary medicines across UK, EU, and ROW markets. We apply the same rigour to veterinary product registrations and pharmacovigilance that we bring to human medicines.
Virtual MAH, fractional QPPV, and outsourced regulatory operations — set up and run for you. PharmaRevix gives virtual and small pharma companies the senior regulatory expertise of a large team, without the headcount.
Submissions supported across UK, EU, US, GCC, APAC, and LATAM — one partner for every market.
No junior delivery without expert oversight. Projects delivered to inspection-ready standards with no critical findings.
eCTD publishing, QMS audits, regulatory strategy, and round-the-clock pharmacovigilance — recognized across sectors.
Don't see your sector? Talk to us — we work across the wider life-sciences landscape.
Ask us anythingPharmaRevix serves six industries: pharmaceuticals (generics, innovators, OTC, biosimilars), biotech and biopharma, medical devices and IVDs, nutraceuticals and cosmetics, veterinary products, and virtual or small pharma companies needing outsourced regulatory and PV operations.
Yes. PharmaRevix offers virtual MAH (Marketing Authorization Holder), fractional QPPV, and outsourced regulatory operations — designed for small and virtual pharma companies that need senior expertise without building an in-house team.
Yes. PharmaRevix provides regulatory strategy, technical documentation, and post-market vigilance (materiovigilance) for medical devices and IVDs under EU MDR, IVDR, UKCA, and global frameworks. This includes serious incident reporting, FSCA/FSN coordination, and PMS planning.
Yes. PharmaRevix integrates regulatory affairs and pharmacovigilance under one coordinated team — so there are no handoff gaps between the team managing your submissions and the team managing your safety data. This integration is a key differentiator for clients across all six sectors.
We work across the wider life-sciences landscape. Tell us about your product and target markets — we'll tell you what's possible.
