Drug & Medical Device Registration
We provide gateways for global market access by supporting product registration in international markets including preparatory services for regulatory submission (risk/therapeutic product category classification, registration requirement, regulatory strategy and roadmap planning), execution of regulatory submission (gap assessment, CTD development, adaption & organization of submission justifications, pharmaceutical and medical device registration, regulatory submission and liaison, adaptation of packaging artwork and leaflet), and post launch regulatory support and compliance.
- Preparatory Services for Regulatory Submission
- Regulatory Liaison
- Execution of Regulatory Submission
- Gap assessment for regulatory submission
- Advisory and coordination of deficiencies identified during gap assessment
- Onsite GxP mock audits with manufacturers
- CTD writing, adaption & organisation of submission justifications, data and supporting documentations to meet local regulatory requirements
- Review of packaging artwork and leaflet
- Certified language translation for dossier and artwork/leaflet as required by local regulators
- Publishing of dossier into local required formats (eCTD, pCTD, hybrid, NeeS)
- Post-Approval Support
Transform business objectives, ideas, related data, documents and materials, into engagement pieces that will resonate with the target audiences. We support medical affairs, marketing, market access, research and regulatory functions, and produce materials such as product brochures, opinion articles, journals, publications, presentation decks and blogs.