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)
Company Details
- Employees
- 4
- Founded
- -
- Address
- 900 Chapel St, Suite 620,argentina
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- http://www.pkinetix.com
- Keywords
- Latin American Clinical Trials, Latin American Regulatory Affairs, Latin American Business Development, In-Licensing, Out-Licensing, Lifecycle Management, Drug Safety & Pharmacovigilance, Orphan Drugs, Rare Diseases, M&A Support, Strategic Partnerships, Competitive Intelligence, Biosimilars Manufacturing, Biosimilars Licensing.
- HQ
- New Haven, Connecticut
Pkinetix Latin America Questions
Pkinetix Latin America's website is http://www.pkinetix.com
Pkinetix Latin America's LinkedIn profile is https://www.linkedin.com/company/pkinetix
Pkinetix Latin America has
4 employees.
View email and phone details for 4
employees at Pkinetix Latin America.
Pkinetix Latin America's industry is
Pharmaceutical Manufacturing
Pkinetix Latin America's top competitors are
Insuvia,
Oncology Ventures,
Lb Investment,
Ceres Group Holdings,
Curatio Therapeutics,
Opko Health, Inc.,
Pro Pharma Research Organization,
Outbound Ventures.
Pkinetix Latin America's categories are Pharmaceutical Manufacturing
Pkinetix Latin America's founding year is 2013
