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NAMSA
About CRO
Contract research organization specializing in medical device testing, biocompatibility, and regulatory consulting for FDA and CE Mark submissions.
Technology & Expertise
Preclinical & Nonclinical Studies, Regulatory Affairs & Submissions, Laboratory Services, Quality Assurance & Compliance form the foundation of our capabilities at NAMSA. By integrating nonclinical programs supporting candidate selection and regulatory milestones; planning and delivery of regulatory documents across development milestones; study-specific laboratory workflows supported by controlled methods and data review; and connected specialist capabilities, we tailor technology and delivery models to each program rather than applying a fixed workflow.
Core Services
Through NAMSA, clients can access Preclinical & Nonclinical Studies, Regulatory Affairs & Submissions, Laboratory Services, Quality Assurance & Compliance. Typical programs draw on in vitro and in vivo study design, safety assessment, and translational evaluation; regulatory strategy, dossier development, submission management, and authority support; laboratory testing, method execution, sample analysis, and scientific reporting; and connected specialist capabilities, with scope and delivery locations agreed around the asset, protocol, and development plan.
Accreditations & Compliance
We maintain controls for documentation, training, issue management, and data integrity within the scope of clinical and regulatory activities. NAMSA confirms facility-specific licenses and certifications as part of project qualification.
