Global Regulatory Affairs and Integrated Services for Market Access
We provide comprehensive, end-to-end Regulatory Affairs support combined with a suite of integrated services designed to streamline product development, registration, and post-approval compliance across global markets.
- Regulatory strategy development and comprehensive gap analysis
- Regulatory submission through CP, MRP, DCP or National routes across EU member states/UK.
- Dossier authoring (Modules 1–5), eCTD compilation, publishing, and submission
- DCP slot request and Centralised Procedure (CP) eligibility request coordination
- Expert response to health authority queries
- EU/UK MAH support
- EU/UK PSMF and EU/UK QPPV support
- EU/UK Batch Release and EU/UK Batch testing support
- EU/UK QP Audit and EU/UK QP declaration support
- Full support for EU GMP inspections and certification
- Management of National phase after closure of MRP/DCP and CPs.
- PIL readability user testing & bridging report preparation
- SME status assessment to benefit from regulatory fees reduction
- Translation Services for Product Information (SmPC, PIL, Labelling) compliant with QRD templates
- Lifecycle Management: Variations (Type IA/IB/II), Renewal, MAH transfer, PSUR
- Scientific advice preparation and briefing documentation
- Orphan drug and pediatric investigation plan (PIP) applications
- Regulatory Medical Writing: Modules 2.4/2.5/2.6/2.7, Module 171, Risk management plans (RMPs), Environmental risk assessment report
- Comprehensive product licensing and regulatory support across all GCC countries, including dossier review, gap analysis, and authority submissions.
- Patent search and evaluation services to ensure IP compliance and market exclusivity strategies.
- End-to-end dossier preparation tailored to GCC regulatory authority requirements, including CTD/eCTD formats.
- Strategic commercialization planning, aligning regulatory timelines with market launch objectives.
- Artwork and labeling localization as per country-specific guidelines in Arabic and English.
- Full coordination of MAH transfers and post-approval variation submissions.
- Local Representation support across the GCC
- Local MAH Setup Support Services
- Technology transfer and localization project management, including site registration and GMP compliance alignment.
- Regulatory intelligence and market entry advisory, keeping you updated on evolving GCC health authority regulations.
- Health Canada Submissions: NDS, ANDS, SNDS, CTA, DIN, Biologic & Device Licenses
- Regulatory Strategy: Pathway assessment, regulatory roadmap, Health Canada consultations, Gap analysis against Canadian regulatory requirements
- Dossier Support: CTD/eCTD preparation, quality (CMC) documents, labeling & monographs, submission via CESG
- Medical Device Compliance: MDEL, Class I–IV licensing, CMDR alignment, SaMD support* Health Canada Submissions:
- Maintenance Services: Renewals, variations, labeling updates
- Clinical Trial Support: CTA preparation, ethics submission, importation guidance
- Pharmacovigilance: PV system setup, AE reporting, PSURs, RMPs
- GMP & Licensing: Establishment licenses, GMP audits, site registration
- Translation & Labeling: English/French compliance, packaging review
- Health Canada Liaison: Representation, Responding to Health Canada deficiency letters (Clarifaxes, Screening Deficiencies, NODs), change management, Pre-submission meetings and Scientific Advice support
- Regulatory Strategy: Product classification, TGA pathway assessment
- Dossier Preparation: CTD compilation for prescription, OTC, and complementary medicines
- Product Registration: TGA submissions for medicines, biologics, and medical devices
- Medical Device Support: ARTG inclusion, GMDN coding, TGA conformity assessment
- Labeling & Compliance: Australian labeling review, regulatory text development
- Regulatory Maintenance: Variations, renewals, and post-approval changes
- Pharmacovigilance: Local PV compliance, AE reporting, RMP submissions
- TGA Liaison: Pre-submission advice, response to queries, and deficiency letters
- Regulatory Strategy: Product classification, Medsafe pathway assessment
- Product Registration: New Medicine Applications (NMA), Changed Medicine Notifications (CMN)
- Dossier Preparation: CTD format submission for prescription and OTC medicines
- Medical Device Registration: WAND database notification for devices
- Labeling & Packaging Compliance: Medsafe-compliant labeling review and approval
- Regulatory Maintenance: Variations, renewals, safety updates
- Pharmacovigilance: Local PV setup, AE reporting, safety monitoring
- Authority Liaison: Communication with Medsafe, deficiency response support
- Regulatory Strategy: Market entry planning, country-specific guidance
- Dossier Support: CTD/ACTD preparation, product registrations, WHO PQ support
- Authority Liaison: Local representative coordination, agency communication
- Labeling & Translation: Country-specific labeling, multilingual artwork compliance
- Maintenance: Renewals, variations, lifecycle management
- GMP & Import Licensing: GMP readiness, import/export licenses
- Pharmacovigilance: Local PV setup, AE reporting, compliance support
Get In Touch
+91 9099123156bd@unicorpharma.com