We provide both off-site and on-site support. The company employees manage projects for a variety of clients ranging from large multinational pharmaceutical organisations to SMEs taking innovate products to the EU market.

We also have a network of flexible regulatory consultants covering same range of activities in other countries of central and east Europe.

1. Medical writing

• Dossier preparation (writing modules 2, 4 & 5 for original, generics, WEU, hybrid, THMP applications)
• Periodic Safety Update Report (PSUR) writing
• Summary of Product Characteristics (SmPC)
• Patient Information Leaflet (PIL)
• Direct Healthcare Professional Communication, DHPC

2. CMC & Manufacturing

• Dossier preparation – modules 2&3 (registration, variations, renewals)
• Expert reports – ERA, PDE etc.
• Contract QP
• GMP audit

3. Regulatory affairs

• Registration strategy
• Regulatory compliance – Gap analyses/Due Diligence Reports
• MA applications and submissions (DCP, MRP and NP) preparation
• Communication with competent authorities
• Life-cycle management (variations, renewals, line extensions, annual reporting) eCTD/NeeS publishing