Batch release, dossier diligence, PV audits, gap analysis, and market access strategy — practical support from someone who stays until it's done.
Most of what I do falls into one of three areas: keeping your licences in good shape, making sure your safety reporting actually works, and getting your regulatory submissions through without unnecessary back-and-forth.
In practice that means QP and RP batch release, GMP/GDP gap analysis, dossier diligence before you file, PV system audits that go beyond ticking boxes, and market access strategy that accounts for how regulators actually think — not just how the guidance reads on paper.
I work with generic pharmaceutical companies, virtual MAHs, contract manufacturers, and importers. Most clients come to me when something needs fixing properly, or when they're building a compliance function from scratch and need someone who's done it before.
Named QP, RP, and RPi on live licences — I carry the personal liability, so I take it seriously.
Everything I deliver is written with one question in mind: would this hold up if an MHRA inspector asked about it tomorrow?
Gap analysis, implementation, troubleshooting — I stay through the messy middle until the system actually works.
QP, RP, and RPi services for marketing authorisation holders, wholesale distributors, and importers — plus GMP/GDP auditing and inspection readiness.
End-to-end safety and vigilance support — from PV system establishment and PSMF maintenance through to expedited reporting and MHRA Gateway submissions.
Strategic regulatory support from initial MA applications through post-approval lifecycle management — variations, renewals, dossier diligence, deficiency responses, and market access strategy.
Qualified Person services for the certification and batch release of medicinal products in compliance with EU GMP Annex 16 and UK requirements. Every batch is personally reviewed — CoAs, manufacturing records, deviations, and transport data.
Named Responsible Person and Responsible Person for Import services for wholesale distribution and importation under MHRA licensing. Active oversight of GDP compliance, cold chain integrity, and supply chain operations.
Expert consultancy and auditing to ensure operations meet current Good Manufacturing Practice and Good Distribution Practice standards. Gap analysis, supplier auditing, and quality system improvement.
Prepare for MHRA inspections and maintain ongoing compliance with evolving pharmaceutical regulations. From mock inspections through remediation and post-inspection CAPA management.
End-to-end pharmacovigilance support ensuring compliance with UK GVP, HMR 2012, and international safety reporting obligations. From PV system establishment for new MAHs through to ongoing signal detection and regulatory submissions.
Strategic regulatory affairs support across the product lifecycle — dossier diligence before you submit, MA applications, post-approval variations, and market access strategy that balances regulatory requirements with commercial reality.
Core Service
Disciplines
Active QP, RP & RPi
Designations Held
Licence Types
Supported
Regulatory
Frameworks
I've sat in enough inspection back rooms and reviewed enough failed dossiers to know that what most companies need isn't more advice — it's someone who'll actually roll up their sleeves and fix things.
Tell me what you're dealing with. If I can help, I'll tell you how. If I can't, I'll say so.
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