Established distribution network with key decision makers on the local markets
First in class partners and alliances in hospital products with focus on oncology and rare diseases
Geography: Europe, Middle East, Asia and EEU to deliver global standard quality services
Field based market access managers
Medical managers and KOL engagement strategy
Extensive knowledge of the local regulations and culture in the region
MARKET RESEARCH and business case preparation
As country and pharmaceutical industry experts we can prepare business case and business plan / strategy to enter Europe, MENA countries, EEU and CIS markets.
Legal framework analysis
Drug eligibility for named patient use
Disease awareness and KOL management
Road map to market access before registration
MARKET ACCESS
Before marketing authorization
Disease awareness and pre-launch activities
Federal and regional budget holders mapping
During marketing authorization process
Preparation of national Pricing & Reimbursement applications
Preparation of product inclusion in reimbursement and in Essential Drug List (EDL)
Interaction with budget holders and KOLs
Negotiation with the authorities
After marketing authorization approval
MONZAIQ PROPOSE:
Patients search and diagnostics
Patients search through diagnostics process setup: Hospital and MDs recruitment and education based on therapeutical area, samples logistics, laboratory recruitment, calibration and validation.
Named Patient Use Programs
Leading full NPU cycle according to the legal requirements. Organizing documents flow, logistics and drug delivery to the patient.
Regulatory Affairs
Compliance and quality management
Marketing authorization
GMP
Distribution
Ready to go distribution solution, including both own distribution network and own distribution license and strong distribution partnership with niche distributors.