Compliance You Can Count On
Before, During, and After Every Shipment

Our in-house regulatory scientists and quality specialists keep your products inspection-ready, your documentation watertight, and your supply chain fully aligned with EU GDP, WHO GSP, and local MOH rules.

Service Modules

Product Registration & Dossier Compilation

  • CTD/eCTD authoring for pharmaceuticals; CSDT and EU MDR Technical Files for devices
  • Local representation and MAH services where required (SFDA, MOH UAE, JFDA, etc.)
  • Response management for agency queries and deficiency letters

Import-/Export-Licence
Management

  • End-to-end filing on Fasah (KSA), e-Mirsal 2 (UAE), Bayan (Oman), and NCTS (Jordan)
  • Serialisation and aggregation data uploads to SFDA Drug Track and DHPO systems
  • Pre-shipment “green lane” clearances to cut border dwell time by up to 48 hours

GDP/GSP Audits
& Gap-Closure

  • Factory, warehouse, and carrier assessments against EU GDP / WHO GSP checklists
  • CAPA action plans with time-bound milestones and re-audit verification
  • Mock regulatory inspections and desk-top documentation reviews

Pharmacovigilance & Post-Market Surveillance

  • Qualified Person for Pharmacovigilance (QPPV) services, ICSRs, PSURs, and RMP updates
  • Field Safety Corrective Action (FSCA) coordination for devices
  • Real-time analytics on adverse-event trends and signal detection

Quality-Management Systems

  • ISO 9001:2015, ISO 13485:2016, and GDP procedure writing, training, and implementation
  • Digital QMS (DocuSign-enabled) with 21 CFR Part 11 audit trails
  • Supplier-qualification programs and ongoing performance KPIs

Training & Competency Building

  • GxP induction for new hires, annual refresher sessions, and role-based micro-modules
  • On-site or virtual auditor-skills workshops, mock recall drills, and cold-chain best-practice labs

5-Step Engagement Model

  • Scoping & Regulatory Gap AnalysisFree baseline check against target-market rules
  • Project Charter & TimelineClear deliverables, responsibilities, and milestones
  • Document Creation & Data CollectionCollaborative authoring on secure portal
  • Authority Interaction & Query HandlingWe draft responses; you approve
  • Lifecycle MaintenanceVariation filings, renewals, and vigilance reporting

Why Clients Choose Our Regulatory Team

  • Middle-East Focus10+ years filing with GCC, Levant, and North-African authorities
  • Full-Service ScopeRegistration, vigilance, quality, and logistics under one contract
  • Rapid TurnaroundAverage dossier submission ⟶ hi-level MOH approval in 14 weeks
  • Audit Readiness100 % client pass rate in SFDA GDP inspections (2022-2024)
  • Data IntegrityValidated electronic systems with role-based access and AES-256 encryption

Ready to De-Risk Your Compliance Journey?

Speak with our regulatory scientists today for a complimentary gap analysis.