Quality systems, supplier audits, inspection readiness and CMC quality, delivered directly by an experienced consultant and sized for companies that don't have a full quality team.
Build a phase-appropriate quality system from the ground up, or fix the one you have. Gap assessments, SOPs, forms and work instructions, document and change control, deviations, investigations, CAPA, training and management review, all set up so a small team can maintain it.
Qualify and audit CDMOs, CROs, laboratories, API manufacturers, packaging suppliers, warehouses and other outsourced partners, plus supplier risk assessments, quality agreements and quality due diligence for partnerships, acquisitions and vendor selection. Audits can be conducted in Spanish.
Quality oversight for clinical and commercial manufacturing, including batch disposition, lot release, quality agreements, technology transfer and validation. Support for clinical supply, IND and NDA document review, NDA submission and commercial launch readiness.
Assess readiness, identify compliance risks, prepare teams and records, conduct mock inspections and support response and remediation activities.
Product evaluation programs that review each product's safety, labeling and ingredients before launch, plus support with FDA product listing and the quality system around it.
An interim or fractional Head of Quality, or project-based support, when you need an experienced quality lead but not a full-time hire: for a QMS build-out, a remediation, an inspection or a launch.
Project-based, fractional and interim engagements, sized to your stage and your team.
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