Organium Your

Partners in Excellence

Since our very beginnings, we at Organium have strongly believed that it is our core values, know-how, people and ethics that set us on the road to becoming the market leader in sustainable solutions services in Saudi Arabia and beyond.

Regulatory Affaris & Pharmacovigilance

Pharmaceuticals
Medical Devices
Cosmeceuticals
Food Supplements

Regulatory Sub -Services

  • Building Regulatory Strategy for GCC & Middle East Region
  • Regulatory systems provision & maintenance
  • Managing a product life cycle (Initial, Variation & Renewals)
  • Dossier Modules Review (Quality, Clinical & Non-Clinical)
  • Dossier transition from NeeS format to eCTD
  • Training Courses on GCC Regulatory Authorities Guidelines.
  • Product Classification services & Pricing forecasts.
  • Managing Scientific Office, Good Manufacturing Practices (GMP) & Good Storage & Distribution Practices (GSDP) inspections
  • Logistics & Distribution Services

Pharmacovigilance Sub – Services

  • PV training & QPPV licensing
  • PV system provision & maintenance
  • PV standard operating procedures
  • Post-marketing surveillance studies
  • ICSR & PSUR assistance
  • Compliance & PV audits preparedness
  • PV master file compilation
  • Comprehensive PV Inspection Management & Post-inspection follow-up

Marketing & Market Access Services

Marketing

  • Product Identity & Branding
  • Portfolio Management
  • Promotional material generation, referencing & update
  • Multi-channel marketing
  • Forecasting & product life-cycle management
  • Resources- Allocation & budgeting consulation
  • Marketing & product differentiation trainings
  • Product Launch Management
  • Market Intelligence & Surveys
  • Tailored Salesforce trainings & Customer Centric Interactions

Market Access Services

  • Commercial Decision Pathways
  • Evidence Generation
  • HTA & HECON Modeling
  • Access Realization & Key Account management
  • Market channels commercials & KAM trainings
  • Pricing Utilization strategies & tools
  • Formulary Management
  • KSLs/KDMs engagement plans
  • Tender Management Services

Medical & Clinical Affairs

Biostatistics

  • Data entry, analysis & generation data validation
  • Training and consulting services
  • Seminars and workshops

Advisory Boards

  • KDMs involvement and contracts
  • Tailored Gap analysis and fulfillment
  • Advisory boards minutes and recommendations
  • KDMs follow-up and phasing arrangements

Local Data Management & Publications

  • Epidemiological data generation & monitoring
  • Non-interventional studies assistance
  • PI & research teams management
  • Registries foundation & maintenance
  • Local Data Generation, Management & Publication
  • Clinical Data Management(CDM)
  • Clinical Trials Management Systems(CTMS)
  • Clinical Trials management system provision and maintenance.

Quality Assurance & SOPs

  • Clinical trials master file
  • Site-selection and on-site monitoring
  • Quality management systems
  • SOPs compilation, provision and archiving
  • Clinical trials master file management

Medical Science Liaison (MSL) Services

  • Therapeutic area & product knowledge training
  • Medical societies partnership programs
  • SLs engagement plans & gap fulfilment
  • Promotional material medical revision & referencing
  • Inclusion files compilation & finalisation

Scientific Leaders Engagement Plans

  • Speaker forums & Regional summits
  • Train the trainer programs
  • Speaker-Development Programs

 

Medical Events Management

Global Congress & Forums

  • Concept and Content generation
  • Financial Managment Program development
  • Speaker engagement
  • Volunteers training and supervision

Digital & Multi-channel Marketing

  • Visual and digital content generation
  • 3D designs and Styrofoam
  • Videography & Photography
  • Sound and Lighting engineering

Exhibition Management

  • Event branding and marketing
  • Creative and tailored booth designs
  • Space management and fulfillment
  • Invitation, registration and evaluation database

Public / Private Venues

  • Access several venues in the region
  • Hospitality and accommodation services

Content Development & Management

  • Speakers’ Contracting & engagement services
  • Agenda & slides development and distribution
  • Content Management System