Registration.Market Access.Distribution.Wholesale.
ALPHA-MEDICAL d.o.o. is a Croatian pharmaceutical partner supporting manufacturers through registration, in-licensing, market access, wholesale and distribution.
Regulatory standing
Quality & complianceHALMED WDL
EU GDP
ISO 9001
ISO 14001
EudraGMDP
AmCham
01 / History in brief
Operating in the Croatian pharmaceutical market since 1991.
1991
Founded as Alfa-Med d.o.o.
2000
Company name changed to ALPHA-MEDICAL d.o.o.
2023
Founded Opus-Medici d.o.o. — affiliated company.
ALPHA-MEDICAL d.o.o. was founded as Alfa-Med d.o.o. in 1991 and is owned by holding company LIVIA d.o.o. The company was established as agent and distributor of the Wellcome Foundation Ltd. until Wellcome was integrated with Glaxo.
The company name was changed to ALPHA-MEDICAL d.o.o. in 2000. ALPHA-MEDICAL developed dynamically and employs specialists required for company development, and is active and successful in the registration of planned drugs, market access, distribution and trade.
ALPHA-MEDICAL is listed in EudraGMDP.
03 / Business activities
Integrated support for manufacturers and partners entering the Croatian market.
From regulatory registration through licensed wholesale and direct hospital supply — ALPHA-MEDICAL covers every step of the pharmaceutical commercialisation chain in the Croatian healthcare market.
Registration & Market Access
Registration of pharmaceuticals including pricing, reimbursement and full market-access pathways under HALMED procedures.
In-Licensing in ALPHA-MEDICAL's name
In-licensing of medicinal products from European and international manufacturers in ALPHA-MEDICAL's own name as Marketing Authorisation Holder.
Distribution in partners' name
Pharmaceutical distribution operated under HALMED WDL on behalf of partner manufacturers across the Croatian market.
Wholesale & direct supply
Wholesale and direct supply to Croatian hospitals, polyclinics and pharmacies under EU GDP guidelines.
Field sales representation
Dynamic sales representative teams covering hospitals, polyclinics and doctors across the Croatian healthcare network.
04 / Product portfolio
Two regulatory pathways, one operational backbone.
The complete portfolio is available on the dedicated pages, with HALMED register links, strengths and pharmaceutical forms for every product.
Marketing Authorisation Holder
In-Licensed Drugs
Medicinal products for which ALPHA-MEDICAL holds the Marketing Authorisation in Croatia, in-licensed from European and international manufacturers.
View portfolioDistribution under HALMED WDL
Drugs in Distribution
Medicinal products distributed by ALPHA-MEDICAL in the name of partner manufacturers under HALMED wholesale licence.
View portfolio05 / Quality & Compliance
Regulated, audited and documented.
ALPHA-MEDICAL operates under HALMED supervision and maintains certifications aligned with EU pharmaceutical distribution and quality standards.
Documentation
Compliance records on file
- HALMED WDL
HALMED WDL
Wholesale Distribution Licence issued by the Agency for Medicinal Products and Medical Devices of the Republic of Croatia.
- EU GDP
EU GDP
Operations aligned with EU Good Distribution Practice guidelines for medicinal products for human use.
- ISO 9001
ISO 9001
Certified quality management system covering operations, documentation and traceability.
- ISO 14001
ISO 14001
Certified environmental management system aligned with EU standards.
- EudraGMDP
EudraGMDP
Listed in the EudraGMDP database for GMP and GDP compliance across the EU supply chain.
06 / Manufacturing partners
Long-term partnerships with international manufacturers.
ALPHA-MEDICAL has developed reliable cooperation with a large number of pharmaceutical manufacturers worldwide since it was founded in 1991.
07 / Contact
Discuss in-licensing, registration or distribution in Croatia.
We support international manufacturers entering the Croatian healthcare market. Get in touch with the ALPHA-MEDICAL team.
Head office
ALPHA-MEDICAL d.o.o.
- Dragutina Golika 36
HR-10000 Zagreb, Croatia, EU - +385 1 3665 093
- info@alpha-medical.hr
Mon–Fri, 07:00 – 15:00
HR VAT: HR47685685842