MD - Pharm, s.r.o.

MD-PHARM, s.r.o. – is Czech privately owned company engaged in pharmaceutical field since 1994. The Company is based in Kravare, near Opava in the Northern part of the Czech Republic in the Central Europe

MD-PHARM, s.r.o. – offers complex services in pharmaceutical field, has experienced and internationally trained staff and contacts to the most important external experts throughout Europe

Main Activities

1. TRADING WITH ACTIVE PHARMACEUTICAL INGREDIENTS (APIs)

• Own warehouse in Kravare
• Certificate of Good Distribution Practice (GDP)
• Permission for handling and storage of psychotropic and dangerous chemicals
• World-wide reliable sources with corresponding documentation (GMP, DMF/EDMF, CEP/COS, BSE/TSE, OVI, Cosher certificate etc.)
• Representation of foreign companies
• Regular trading with 100-120 items (export/import into more than 45 countries)

2. REGULATORY AFFAIRS

Pre-submission service:

• Arrangement of the preclinical, bioequivalence and clinical studies
• Arrangement of dossiers for registration according to EU requirements in eCTD
• Expert reports – Quality Overall Summary, Preclinical and Clinical Overview and Summary
• Preparation of SPCs, leaflets, packs, etc. in local languages in QRD
• Preparation of readability tests
• Re-format of registration dossiers into eCTD

Registration service:

• National, MRP and DCP procedures
• Representation of foreign companies
• Maintenance of registration

Pharmacovigilance service

Reimbursement and maximum price service for medical products Focussing on the CEE countries (CR, SK, PL, SL, EE, LT, LA, HU, RO, BG, SI, etc.)