Unlicensed medicines

Import and distribution of unlicensed products (medicines registered at country of origin but not registered at country of importation).
Through our own wholesale company we are delivering unlicensed products to the end users (either it is a niche, orphan drug or product in current shortage on specific market).
Therapeutic areas in which we are present: oncology, hematology, infectious diseases, cardiology, anesthesia, neurology, gastroenterology, urology and psychiatry.
Our main clients are clinic’s, clinical hospital centres, institutes, general hospitals and pharmacy’s, both state and privately owned.

Registration of medicines and medical devices

Pharmaceutical market analysis for your portfolio and market opportunity analysis.
Regulatory services for the release of the products on the market are covering the whole process of product registration/maintenance of MA and all processes within Competent Authorities that precedes the product marketing.
Support prior to the issuance of the MA, preparation and submission of applications, supplementation of the documentation upon request of the competent authority, procedural advices, contact with the competent authority.
Preparation and review of translations of the product information (SmPC, PIL, labelling) in accordance with the national requirements.
Pricing (preparation and submission of application for max. WHS price approval and for application for inclusion into Reimbursement List of National Health Insurance Fund accordingly).

Managed access programs for original and innovative medicines

Company establishes Managed Access Programs on behalf of innovators to capture and serve HealthCare Provider’s requests for access in non-launched markets.
We provide a full commercial infrastructure and manage all aspects of the operation for specialty, rare disease and biotech companies, including registration, medical affairs and PV, logistics and territorial coverage as well as sales and marketing programs.
We ensure disease awareness, consistent messaging to the community, and we deliver best practices through a dedicated team of highly experienced MSLs and KAMs allowing fast track access to innovative medicines and fulfil unmet medical needs.
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