🌍 Your Life Science Strategic CRO Partner in Clinical Trials & Regulatory Development. From Clinical Innovation to Go-To-Market Success
🔬 ESTERN Medical CRO Life Sciences
In today’s rapidly evolving Life Sciences ecosystem, innovation alone is not enough. True success requires precise execution across Clinical Development, Regulatory Affairs, and Go-to-Market (GTM) strategies.
At ESTERN Medical CRO Life Sciences, we partner with Biotech, Pharmaceutical, Medical Device, and R&D organizations to transform groundbreaking scientific discoveries into market-ready solutions.
Headquartered in the Boston–Cambridge Genetown hub, and supported by expert regional management teams across the U.S. 🇺🇸, Mexico 🇲🇽, Colombia 🇨🇴, Chile 🇨🇱, Argentina 🇦🇷, and Brazil 🇧🇷, we offer International capabilities with deep regional expertise. Our operations are fully aligned with the regulatory requirements of FDA, EMA, COFEPRIS, ANVISA, INVIMA, ANMAT, and ISP, ensuring both speed and compliance across markets.
Our integrated Full-Service CRO model enables us to:
• Design and conduct Phases I, II, III & IV Clinical Trials
• Plan and submit IND & NDA filings
• Navigate 510(k), PMA, and IDE regulatory pathways
• Align regulatory strategy with Go-To-Market GTM execution, ensuring faster approvals, reduced risk, and maximized market impact.
From biologicals and biosimilars to small molecules and breakthrough medical technologies, ESTERN Medical accelerates product development, strengthens regulatory positioning, and drives market access across the U.S., North America, and Latin America (LATAM).
🚀 How We Empower Your Success:
• 🧬 Clinical Trials: Phases I, II, III & IV for Biotechs & Pharma
• 💉 Medical Device Trials: 510(k), PMA, IDE pathways
• 📋 IND & NDA Planning & Submissions
• ⚖️ Regulatory Affairs: U.S. & LATAM strategies
• 🌐 Go-To-Market (GTM) Strategy & Market Access
• 🔎 Strategic Consulting: R&D through commercialization
• 📈 RWE & RWD Integration
Company Details
- Employees
- 30
- Founded
- -
- Address
- 955 Massachusetts Ave., No. 203,colombia
- Phone
- 617-395-0204
- in****@****cal.com
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- esternmedical.com
- Keywords
- Clinical Research Development, Clinical Trials, Clinical Research Organization, Latin America Clinical Trials, Regulatory Affairs, CRO South America, CRO US North America, Contract Research Organization, CRO Latin America, CRO Emerging Markets, Cardiology Trials, Oncology Trials, Medical Devices, IND, NDA, PMA, 510K, Pharmaceutical Clinical Development, Emerging Markets, CNS Trials, Clinical Trial Rescue, Phase I, Phase II, Phase III, Phase IV, Consulting, Biotechs, Monitoring, Site Selection, Project Management, Latin America, CRO USA, CRO Boston, International CRO, CRO Mexico, CRO Chile, CRO Argentina, CRO Brazil, CRO Colombia, R&D, MedTech, Boston CRO, Massachusetts CRO, Cambridge CRO, Biotechs, Pharmaceuticals, Clinical Trials Consulting, Clinical Research, LATAM, life sciences, life science, Covid, Infectious diseases, Covid-2019, cardiology, Medtechs, MRI, MRA, Oncology, Medical Devices, RWD, RWE, New England, Biotechnology, Clinical Research, Contract Research, Drug Development, CRO, radiopharmaceuticals, Class III Medical Devices, Clinical Development, Regulatory Clinical Trials Strategy, Emerging Markets, CRO New England, Life Sciences, Biotech, EMEA, FDA, Invima, Cofepris, ANMAT, MoH, EC/IRB, ISP Chile, Anvisa, GTM, Go To Market, Pharmaceutical Product Registration, Clinical Regulatory, Latin America, US North America, South America, GTM, Go To Market Life Sciences, GTM Pharmaceutical, GTM Biotech, GTM Medical Devices, GTM Regulatory, GTM Latin America.
- HQ
- Cambridge, MA
- Competitors
- Kinentia Biosciences is a contract research and manufacturing organization based in Albany, NY., PDB Clinical Research Organization, X7 Research - full-service contract research organization, Remo Contract Research Organization, Margan Clinical Research Organization, CLINMARK - CONTRACT RESEARCH AND CONSULTING ORGANIZATION, CROTURK - Full Service Turkish Contract Research Organization - CRO TURK, Contract Research Organization for Medical Devices & Services, Pepgra Clinical Research Organization (CRO) for Medicines and Healthcare products, Clin4all Clinical Contract Research Organization (CRO) France.
Estern Medical Cro Life Sciences-Bridging Usa & Latin America Clinical R&d Pharma| Biotechs| Medtech Questions
Estern Medical Cro Life Sciences-Bridging Usa & Latin America Clinical R&D Pharma| Biotechs| Medtech's helpline number is 617-395-0204
Estern Medical Cro Life Sciences-Bridging Usa & Latin America Clinical R&D Pharma| Biotechs| Medtech's website is esternmedical.com
Estern Medical Cro Life Sciences-Bridging Usa & Latin America Clinical R&D Pharma| Biotechs| Medtech's LinkedIn profile is https://www.linkedin.com/company/estern-medical
Estern Medical Cro Life Sciences-Bridging Usa & Latin America Clinical R&D Pharma| Biotechs| Medtech has
30 employees.
View email and phone details for 30
employees at Estern Medical Cro Life Sciences-Bridging Usa & Latin America Clinical R&D Pharma| Biotechs| Medtech.
Estern Medical Cro Life Sciences-Bridging Usa & Latin America Clinical R&D Pharma| Biotechs| Medtech's industry is
Pharmaceutical Manufacturing
Estern Medical Cro Life Sciences-Bridging Usa & Latin America Clinical R&D Pharma| Biotechs| Medtech's top competitors are
Kinentia Biosciences Is A Contract Research And Manufacturing Organization Based In Albany, Ny.,
Pdb Clinical Research Organization,
X7 Research - Full-Service Contract Research Organization,
Remo Contract Research Organization,
Margan Clinical Research Organization,
Clinmark - Contract Research And Consulting Organization,
Croturk - Full Service Turkish Contract Research Organization - Cro Turk,
Contract Research Organization For Medical Devices & Services,
Pepgra Clinical Research Organization (Cro) For Medicines And Healthcare Products,
Clin4all Clinical Contract Research Organization (Cro) France.
Estern Medical Cro Life Sciences-Bridging Usa & Latin America Clinical R&D Pharma| Biotechs| Medtech's support email address is info@esternmedical.com
Estern Medical Cro Life Sciences-Bridging Usa & Latin America Clinical R&D Pharma| Biotechs| Medtech's categories are Pharmaceutical Manufacturing
Estern Medical Cro Life Sciences-Bridging Usa & Latin America Clinical R&D Pharma| Biotechs| Medtech's founding year is 2002
