Independent GxP Audit & Advisory for Brand Owners and Sponsors
When you outsource manufacturing, you retain the regulatory accountability. Vitalane provides independent GxP quality audits and advisory to brand owners, sponsors, and companies managing contract manufacturing networks — so you know exactly what you are accountable for.
Active across regulatory frameworks
Active across
Independent GxP Quality Audit & Advisory
From supplier qualification audits and CMO oversight to ICH E6(R3) gap assessments and quality agreements — Vitalane gives brand owners and sponsors the independent assurance their supply chain requires.
Supplier & CMO Audits
Independent qualification and periodic oversight of contract manufacturers, API suppliers, packaging suppliers, and testing laboratories. Risk-ranked findings linked to product, patient and compliance impact, with CAPA review and close-out support.
Learn more→GMP Audits & Inspection Readiness
Independent GMP assessments and inspection-readiness reviews against applicable TGA, FDA, PIC/S and EU GMP expectations.
Learn more→Gap Assessments
Structured evaluation of quality systems against current regulatory expectations, producing a risk-prioritised remediation roadmap for new market entries, new CMO relationships, or post-acquisition integration.
Learn more→Quality & Technical Agreements
Drafting, review, and negotiation of Quality Agreements and Technical Agreements between sponsors, CMOs, suppliers, and distributors — defining accountability clearly before manufacturing begins.
Learn more→ICH E6(R3) Advisory
Gap assessments and advisory support for sponsors and CROs adapting to the updated Good Clinical Practice standard — including risk-based monitoring and investigational product supply chain requirements.
Learn more→Regulatory Submissions & Advisory
Support for TGA, FDA, EMA, and NMPA submissions, regulatory query responses, and quality documentation for product registrations and variations.
Learn more→You Are Accountable. We Are Independent.
Regulators hold brand owners and sponsors responsible for the quality of every product — regardless of who manufactures it. Vitalane provides the independent audit and advisory function that gives you objective assurance across your entire supply chain.
Years of Pharmaceutical Quality & GxP Experience
Deep expertise built across pharmaceutical, biotech, and contract manufacturing environments — spanning supplier qualification, CMO oversight, regulatory submissions, and inspection readiness for brand owners and sponsors.
Multi-Jurisdiction Coverage
Australian-based with international quality and regulatory experience across Australia, the US, Europe, the Middle East and Asia — with deep understanding of how TGA, FDA, EU GMP, PIC/S, and NMPA expectations apply to sponsors managing offshore manufacturing.
"Precision in compliance is not optional — it is the foundation of patient safety."
Trusted for the Quality of Our Work
Independent expertise is important. How that expertise is delivered matters too.
“Really appreciate the robust report!”
“We greatly appreciate your timeliness and professionalism in completing the audit.”
Independent. Practical. Professional.
Not Sure Where to Start?
Book a short readiness call with Bright to talk through your supply chain, upcoming inspections, or compliance gaps — no commitment required.
Or call Bright directly to discuss your requirements