Client 1

QMS Architecture for Early-Stage Diagnostics Company

Challenge:

_{Early-stage diagnostics startup preparing for FDA pre-submission required a compliant, investor-ready QMS framework.}

Approach:

_{Designed a phase-appropriate quality system aligned to applicable regulatory expectations, with clearly bounded scope and implementation sequencing.}

Outcome:

_{Achieved internal audit readiness within eight weeks, enabling smoother investor compliance verification and accelerating pre-market submission readiness.}

Project Status:

COMPLETE

Client 2

N/A

Challenge:

N/A

Approach:

N/A

Outcome:

N/A

Project Status:

Onboard