SVC / 01
GMP audits & remediation
Mock audits, supplier audits, gap assessments — and the remediation programme to close every finding before the real inspection.
DeliverableAudit report · CAPA plan
An end-to-end regulatory and quality partner for pharma, medical device, food and cosmetic — covering audit, certification, dossier preparation and post-market lifecycle. Connected to GlobalRegAI for live regulatory intelligence across 22 authorities.
Mock audits, supplier audits, gap assessments — and the remediation programme to close every finding before the real inspection.
ISO 9001 / 13485 / 22000 / 22716 implementation — from gap analysis through to certifying body witness audit, in 6–9 months.
Class I–IIb CE MDR technical files, FDA 510(k) submissions, MDSAP-aligned QMS, and the post-market plan that holds it together.
US, EU, KR and PMDA cGMP — process validation, deviation handling, and the SOP architecture that survives every inspection.
EFSA novel food, FDA NDI, MFDS health functional food, China NHC blue-hat — claim substantiation, label review, dossier.
EU CPSR & PIF, FDA MoCRA registration, China NMPA filings, ASEAN cosmetic — safety assessor sign-off included.
Coordinated multi-market launches — one dossier core, jurisdiction-specific delta packs, and a single regulatory point of contact.
Pharmacovigilance setup, vigilance reports, periodic safety updates, complaint handling, and variation management.
Fastest viable path to market — pre-submission meetings, pathway selection, claim mapping, and competitor benchmarking.
GlobalRegAI is the regulatory intelligence engine that sits behind our consulting practice. It indexes live regulatory text across 22 authorities and lets our team — and our customers — query it in plain language.