ValiCore ADVISORS is a boutique pharmaceutical advisory firm built around one reality: everything in pharma is shaped by regulation. Our practice areas are distinct, yet all rest on that regulatory core. Together they keep your marketing authorisations moving, your quality and data integrity inspection-ready, and your digitalisation and AI programmes governed, validated, and delivered in GMP adherence — combining strategic clarity with pragmatic execution to deliver measurable outcomes for small and mid-size pharmaceutical companies.
Why we exist
So that the pharmaceutical industry can change, modernise and grow without weakening what protects the patient.
Every advance in how medicines are made — a new system, a new technology, a new facility — has to earn the same trust as what it replaces. We exist to make sure it does.
What we offer
Protect what you have built. Shape what comes next.
ValiCore ADVISORS helps pharmaceutical companies protect what they have built and shape what comes next. We keep operations compliant and inspection-ready — and we bring strategy, digitalisation and AI into daily practice without putting compliance at risk.
Regulation at the Core. Advantage All Around.
Regulation is not a constraint to be managed around; it is the design basis. A marketing authorisation dossier written the way the assessor reads it draws fewer questions and fewer clock-stops. A system validated with the inspection in mind is not re-validated after it. An AI use-case classified and evidenced under Annex 11, the draft Annex 22 and the AI Act goes into operation once. ValiCore ADVISORS works where GMP compliance, digitalisation and AI meet — so that every advance in how medicines are made earns the same trust as what it replaces.
How we work
Alongside your team — under your lead or ours.
Pharmaceutical companies and marketing-authorisation holders engage us directly; audit and consulting partners bring us into their projects for specialist depth. In both cases we work alongside your team — on audits, systems, programmes and dossiers — and bring the regulatory, GMP and AI-governance expertise the work needs. Every engagement is a scoped mandate with a defined end and a handover to your team, measured by one standard: it holds up in an inspection.
Explore a strategic partnership
The best work starts with understanding each other. Tell us where you stand and where you want to go — an audit, a new system, an AI use-case, a programme, a dossier — and we bring what we know of the regulator's expectations and the technology. From there, we build it together.
Frequently Asked Questions
We are an advisory firm for the pharmaceutical industry, working where GMP compliance, digitalisation and AI meet. We audit — IT suppliers, contract manufacturers and laboratories, and your own site before the inspector comes — and we help you bring new systems, AI and digital programmes into GMP operation, and your marketing authorisation dossiers through the assessor's review. Every engagement is a defined mandate with a defined end and a handover to your own team.
Mainly small and mid-size pharmaceutical manufacturers and marketing-authorisation holders, contract manufacturers, and the providers of software and AI-driven systems that serve them — as well as audit and consulting partners who bring us into their engagements for specialist depth.
Yes — CTD dossiers, Modules 1 to 3: a preliminary assessment of where your dossier stands, creation and management of the modules with an assessor's eye (M4Q(R2)-aligned, eCTD), and support through the procedure when the authority asks questions.
We conduct the following types of audit: audits of software, SaaS and IT service suppliers, which Annex 11 and Chapter 7 require the regulated company to assess; mock inspections and self-inspections under Chapter 9; and audits of contract manufacturers and contract laboratories. Supplier audits are conducted on behalf of manufacturers and marketing-authorisation holders, or as specialist support inside a partner's audit team. Where an audit reaches into process automation and control, computerised systems and data integrity, or AI-driven software, our subject-matter experts examine those parts of the scope.
Yes — that is what the AI Compass is for: our AI governance framework for finding, classifying, validating and operating AI use-cases under EU GMP Annex 11, the draft Annex 22 and the EU AI Act. Governance is set up first and laid over the AI you already run; validation closes the arc; it ends with an inspection-ready dossier that belongs to you — and your own team trained to maintain it.
Information security management systems are not our practice. Our audits assess GxP-relevant IT controls and flag where NIS2 scope begins - pharmaceutical manufacturers are in scope of the German implementation , in force since December 2025; for ISMS implementation and NIS2 compliance we coordinate with specialist partners.
Validation Package for AI-driven systems and support in deployments: the AI evidence your customers must ask for — at purchase, validation, audit and inspection — built once into the package you already have, kept current per release, in the language their quality functions recognise. Where wanted, we work the first deployments with your team until they carry it alone.
From digital strategy to interim leadership, PMO and change management — hands-on, and always in GxP adherence.
By recusal, written into our contracts: we do not audit validation evidence we have authored, and we do not take an independent-auditor role at a company where we have acted in a supplier's name. Existing relationships are disclosed before any audit mandate is accepted.
Worldwide — on site where the work requires it, remotely where it does not.
With a conversation. A short call to understand your situation; if it fits, we propose a scoped mandate with a defined end. If it does not, we say so.
