Whether you are a manufacturer exploring new markets or a local partner seeking quality pharmaceutical products, our team is ready to help.
We respond to all inquiries within one business day.
Via della Meccanica, 1
36100 Vicenza VI, Italy
Monday to Friday, 9:00 - 18:00 CET
Via della Meccanica, 1, 36100 Vicenza VI, Italy
View on Google Maps →Our in-country partners provide local support across all active markets.
Vicenza, Italy. Central coordination, manufacturer relations, strategic planning, and regulatory dossier management.
In-country regulatory and distribution partner network. COFEPRIS expertise, hospital and pharmacy channel access.
Local regulatory and commercial partner. ANVISA registration expertise, institutional and retail distribution channels.
Colombia, Peru, Chile, Ecuador. INVIMA, DIGEMID, and ISP registration capabilities with local commercial coverage.
Nigeria, Ghana. NAFDAC and FDA-Ghana expertise. Hospital and wholesale distribution partnerships.
Kenya, South Africa, Tanzania. PPB and SAHPRA registration expertise. Public sector and private hospital channels.
We work with finished dosage forms across multiple therapeutic areas, including injectables, nasal sprays, oral solids, and specialty formulations. Our focus is on products with existing FDA, EMA, or WHO prequalification approvals, as these qualify for abbreviated registration pathways in most target markets.
Timelines vary by country and regulatory pathway. Using abbreviated pathways for products with existing FDA/EMA approvals, registration can take as little as 30 days (e.g., COFEPRIS abbreviated pathway in Mexico) to 12 months. Standard pathways typically take 12 to 18 months.
We typically negotiate territory-specific exclusive distribution rights to ensure alignment of investment and incentives. However, we are flexible and can structure non-exclusive arrangements depending on the product and market dynamics.
We work with manufacturers across a range of volumes. For initial market entry, we understand that volumes may be modest and we structure agreements accordingly. Our focus is on building sustainable, growing businesses rather than one-time large orders.
We coordinate pharmacovigilance through qualified local partners in each market. This includes adverse event reporting, periodic safety update reports, and compliance with local pharmacovigilance regulations. We can also assist with Risk Management Plans (RMPs) where required.