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
