Drugs & Pharmaceuticals
Pharmaceutical compliance, from EMA and FDA submissions to GMP and pharmacovigilance
Bringing a medicinal product to market means EMA, FDA NDA/ANDA/BLA, ICH Q/S/E/M guidelines, EU GMP and FDA cGMP, GDP, EU GVP pharmacovigilance, MAH obligations, EU FMD serialisation, and DSCSA traceability — across multiple markets, with strict deadlines. Cleo maps every regulatory obligation per molecule per jurisdiction, so your regulatory affairs and pharmacovigilance teams move faster, with audit trails ready for inspections.
One platform for every market
Cleo maps regulatory obligations for drugs & pharmaceuticals across 106 countries.
Pharmaceutical Product Compliance & Lifecycle Management
Launching a medicinal product across the EU, US, UK, Japan, and emerging markets means navigating EMA centralised/decentralised procedures, FDA NDA/ANDA/BLA, MHRA, PMDA, ANVISA, and ICH Common Technical Document (CTD) requirements — each with different dossier formats, labelling rules, and pharmacovigilance obligations. Cleo maps every step from IND/CTA to MAH lifecycle obligations, with variation tracking, renewal calendars, and serialisation compliance.
- Map EMA, FDA, MHRA, PMDA, ANVISA, Health Canada, and 25,000+ pharmaceutical regulations per molecule per market
- Lifecycle management: variations (Type IA/IB/II), renewals, line extensions, and post-authorisation safety studies (PASS)
- EU FMD and DSCSA serialisation/traceability compliance with NMVS and HDA workflow integration
- Pharmacovigilance: EU GVP modules, FDA FAERS, ICSR submission tracking, PSUR/PADER calendar automation
- Labelling and SmPC/PIL compliance with QRD template alignment and excipient declarations across 27 EU languages
Explore by jurisdiction
See how drugs & pharmaceuticals compliance varies across jurisdictions.
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