Practice Areas
The practices below are distinct; the work rarely stays inside one of them. An audit finding becomes a validation task, a new system reaches into the dossier, a digital programme has to survive the next inspection. We carry the work across those boundaries ourselves, so nothing is lost at the hand-off — and you can start wherever your question is today.
Regulatory Affairs Advisory
ValiCore ADVISORS helps pharmaceutical companies and Marketing Authorisation Holders move faster to market with senior regulatory advisory across the whole procedure: a preliminary assessment and regulatory strategy that shows where your dossier stands, CTD authoring and management of Modules 1 to 3 with an assessor's eye and procedural support through the authority's questions to approval. Our model is built for flexibility: direct partnerships with manufacturers and MAHs, and white-label collaboration with consulting firms seeking specialised regulatory depth.
GMP Advisory
ValiCore ADVISORS delivers independent, risk-based GMP audits of suppliers, CMOs, and internal sites — producing a regulator-ready view of compliance that safeguards product quality, patient safety, and your marketing authorisation. Where audits reach into complex manufacturing, automation, digitalisation, and data integrity, we embed as subject-matter experts alongside auditors and client teams, translating between regulator and engineering language to convert findings into pragmatic fixes that strengthen compliance without stalling production.
AI Adoption, Governance & Validation
With the AI Compass we take AI from use-case to inspection-ready operation — the systems you plan, the ones you already run, and the AI that arrives inside them through vendor updates — classified, validated and kept under control under Annex 11, the draft Annex 22 and the EU AI Act, with Computer System Validation and CSA underneath. We also work on the vendor side: providers of AI-driven systems engage us to build the validation evidence their pharma customers require and to support the first customer deployments.
Digital & AI Transformation
Digital and AI change how a pharmaceutical company makes and releases product — and small and mid-size companies rarely have a standing programme office to carry it. ValiCore ADVISORS takes that role: strategy support, interim leadership, programme coordination and change management, in GxP adherence from the first decision to daily use. The capability stays in your organisation after we leave.
Explore a strategic partnership
Tell us about the project you have in mind. We will say plainly whether and how we can help. Most engagements begin with a short call and a written scope.
