Quality & Regulatory Compliance
International regulatory requirements and predicate IVD identification
Our team assessed the regulatory and logistical barriers to creating an international in vitro diagnostics (IVD) company by interviewing operations managers and business development staff at established companies. The assessment compared and contrasted regulatory hurdles in the United States, China, and Australia and highlighted major barriers specific to each market. In the United States, predicate IVD were identified for possible 510(k) submission. Our recommendations were incorporated into a comprehensive market entry strategy and informed strategic partnerships to aid growth and development.
GLP and CLIA assessment for a laboratory developed test provider
BALSA consultants worked with an emerging diagnostics company on regulatory compliance for their laboratory developed testing services. Our team developed a step-by-step GLP compliance checklist for in vitro diagnostics applied to clinical studies. The assessment outlined important regulatory hurdles required for CLIA certification. Our recommendations included actionable measures to improve compliance and establish the company as a leader in supporting clinical studies.