Pkinetix is a U.S. based consulting company that focuses on helping global pharmaceutical, biotechnology, medical device, healthcare and diagnostic companies succeed in Latin America. We have offices in New Haven, Connecticut and Buenos Aires, Argentina. Services: -Latin American In/Out Licensing support for Biosimilars and Orphan Drugs -Latin American Regulatory Affairs (product registrations, CTA submissions, meetings with regulatory agencies, Orphan Drug Designations, Breakthroughs, Fast Tracks etc) -Latin American Clinical Trials for Rare Diseases -Drug Safety & Pharmacovigilance (ICSR, Aggregate Reports, Signal Detection, REMS, RMPs) -Latin American Lifecycle Management -Latin American Business Development -Latin American M&A support Countries we cover: • Argentina (ANMAT) • Bolivia (AGEMED) • Brazil (ANVISA) • Chile (ISPCH) • Colombia (INVIMA) • Costa Rica (ARN) • Ecuador (ANRCVS) • El Salvador (DNM) • Guatemala (DRCPFA) • Honduras (ARSA) • Mexico (COFEPRIS) • Panama (DNFD) • Nicaragua (DGRS) • Paraguay (DNVS) • Peru (DIGEMID) • Dominican Republic (DGDF) • Uruguay (MSP) • Caribbean (CRS)