Serialisation, simplified

Ankhero is an independent pharmaceutical serialisation and compliance consultancy. With 25+ years of experience, it helps pharmaceutical manufacturers, marketing authorisation holders (MAHs) and contract manufacturers (CMOs) navigate EU FMD, DSCSA and global serialisation mandates — advising on roadmap development, compliance assessment, risk analysis and day-to-day serialisation operations.

Four regulatory blocks. EU FMD: system selection, NMVO onboarding and alert management across the European Medicines Verification System. US DSCSA: T3 data management, trading-partner integration and interoperability guidance for manufacturers and distributors. MEA: Saudi Arabia, Turkey, the UAE and beyond. CIS: national system compliance across Russia, Kazakhstan and the wider CIS region.

No. Ankhero is vendor-neutral and is not tied to a single system or provider. Most advisers in this space also have serialisation software to sell, which shapes their recommendations. Ankhero's role is to help clients choose the right solutions for their situation and integrate cleanly across their existing ecosystem, avoiding unnecessary complexity and vendor lock-in.

Ankhero maps your compliance gap, recommends the right approach for your situation, and gives you a clear path forward. There is no obligation and no sales cycle — the conversation is with a serialisation expert, not a junior consultant.

Pharmaceutical manufacturers, marketing authorisation holders and contract manufacturing organisations that carry serialisation obligations across the EU, US, Middle East and other regulated markets — particularly organisations juggling multiple regulatory frameworks, disconnected systems and partners, and ongoing compliance risk.