Next-Gen Regulatory Protocols & Services
Precision Intelligence for Global Compliance
A specialised portfolio providing end-to-end support across every stage of health registration and regulatory maintenance for Medicinal Specialties, Cosmetics and Medical Devices.
FDA & EMA COMPLIANT GLOBAL GXP STANDARD REAL-TIME DOSSIER TRACKING
MOD_01 · BIO-PHARMA
Medicinal Specialties
Synthetic & Biological ModulesHealth licensing and inspection of manufacturing sites and establishmentsGap analysis and dossier integrity assessmentStructuring, compilation and management of registration applications (CTD/eCTD)Strategic monitoring and active status oversight before authoritiesAPI and sample import proceduresRegulatory intelligence and horizon scanningPre-inspection GMP auditsSupported scientific and technical translations
STATUS: OPERATIONALACTIVE
MOD_02 · DERMO-BIO
Cosmetics and Oral Hygiene
Safety Assessment & Claims ConformityHealth licensing for manufacturers and importersRegulatory support for product importation and releaseTechnical conformity assessment for formulations and ingredient listsClaims and labelling validation under Mercosur / ANMATHealth registrations and notificationsCosmetic GMP auditsFormula, packaging and renewal variationsCosmetic registration licence transfersTechnical and legal advice for commercialisation
STATUS: OPERATIONALACTIVE
MOD_03 · MEDTECH-CE
Medical Devices and IVD
MDR & IVDR Conformity · Risk ClassificationRisk-level categorisation and classification (Classes I to IV)Technical File drafting and auditingStructuring and management of medical device registration applicationsStrategic monitoring and active status oversightLicensing of medical technology importers and distributorsTechnovigilance systems and adverse event managementVariations, extensions of use and health renewals
STATUS: OPERATIONALACTIVE
4-Phase Operating Methodology
Lifecycle Maintenance and Regulatory Process
Phase 1: Assessment (gap analysis and technical audit) | Phase 2: Strategy (dossier structuring and compilation) | Phase 3: Registration management (submission and active follow-up) | Phase 4: Post-authorisation (certificate, pharmacovigilance/PGR and leaflet/QR updates).