LH QUALITY CONSULTING

Pharmaceutical & Biotech Quality Consulting

Experienced QA support for pharmaceutical and biotech organizations from development through commercialization, with direct involvement in quality systems, CMC, manufacturing and regulatory readiness.

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QUALITY LEADERSHIP

Hands-on Quality leadership

Senior hands-on Quality leadership without adding unnecessary layers.

Fractional and interim Head of Quality support
Quality strategy and practical Quality support
Executive quality support
Quality risk management

CMC & MANUFACTURING QUALITY

CMC & manufacturing quality

Quality oversight across development, clinical and commercial manufacturing.

CMC Quality oversight
Technology transfer and scale-up
Validation and qualification oversight
Batch disposition and lot release
Commercial readiness

PHARMACEUTICAL QMS

Pharmaceutical QMS

Build, remediate and maintain phase-appropriate quality systems.

QMS design and implementation
SOP development
CAPA and investigations
Change control
Management review and training

NEED QUALITY SUPPORT?

Let's discuss your quality or compliance challenge.

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