Quality support for pharmaceutical, biotechnology, medical device, combination product, 503B and cosmetic companies. Most clients are early-stage, virtual and growing companies that rely on outsourced manufacturing.
Hands-on quality support from early development through commercial manufacturing, including QMS, CMC Quality, supplier oversight, GMP and inspection readiness.
Quality systems and supplier oversight for regulated medical devices and drug-device combination products.
Quality support for 503B outsourcing facilities and cosmetic organizations, including MoCRA compliance and quality-system needs.
Project-based, fractional and interim engagements, sized to your stage and your team.
Let's Talk