Regulatory
affairs - consulting services, regulatory strategy,
development and FDA liaison, product approval applications,
and regulatory compliance.
Quality
- manufacturing auality, QSR/GMP compliance and
quality assurance program analysis, and process
validations.
Clinical
- study design and protocol development, regulatory
submissions & investigational approval process,
study management, data management and analysis,
study monitoring, and study reports.
EM lab
- on-site electromechanical laboratory.
Incubator
- provides international companies an instant presence
in the US market.
Diagnostics
- on-site In Vitro Diagnostics (IVD) Laboratory.
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