Vitalane GMP Consulting

Independent GxP Quality Audit & Advisory

Independent Quality Assurance for Brand Owners and Sponsors

When manufacturing is outsourced, quality and regulatory accountability remain with the brand owner or sponsor.

The Vitalane Story

VITALANE provides independent GxP audit and quality advisory services, helping organisations understand, assess and manage quality risks across outsourced manufacturing and supply chains.

Led by Bright Gnanaselvam, a senior pharmaceutical quality professional and lead auditor with more than 20 years of international GxP experience, VITALANE provides clients with direct access to experienced, independent quality expertise.

Our approach is practical and risk-based — focused not simply on identifying compliance gaps, but on understanding their potential impact on product quality, patient safety and regulatory compliance.

Bright Gnanaselvam — Principal Consultant, Vitalane GMP Consulting

What We Stand For

The principles that guide every engagement, every report, and every recommendation.

Genuine Independence

Vitalane has no commercial relationship with the CMOs and suppliers it audits. Assessments reflect what the evidence and regulations require — giving brand owners and sponsors an objective view they cannot get from an embedded QA function.

Sponsor-Side Perspective

Vitalane works for the brand owner or sponsor — not the manufacturer. That means audit findings, risk ratings, and remediation recommendations are framed around your regulatory accountability, not the site's commercial interests.

Audit-Led Methodology

Every engagement starts with an objective assessment of what is actually in place — not what documentation says should be. Findings are evidence-based, risk-rated, and inspection-ready.

Current Regulatory Intelligence

Regulatory expectations for outsourced manufacturing evolve constantly. Vitalane stays current with guidance updates, inspection trends, and enforcement actions so clients are always ahead of the curve.

Bright Gnanaselvam

Every engagement is conducted by Bright directly — not delegated to a junior associate. When you work with Vitalane, you work with the practitioner.

BG

Bright Gnanaselvam

Founder & Principal Consultant

MSc Pharmaceutical Sciences | MRSC | 20+ Years Pharmaceutical Quality & GxP Experience

Bright founded Vitalane to provide genuinely independent GxP quality audits and advisory to brand owners, sponsors, and companies managing outsourced manufacturing networks. His career spans supplier and CMO qualification, GMP auditing, regulatory submissions, quality system design, and inspection readiness across the Middle East, Europe, and Oceania — giving clients the sponsor-side perspective and multi-jurisdictional depth that is rare in independent consulting.

Supplier & CMO qualification auditsSponsor-side GxP oversightTGA, FDA & EU GMP frameworksQuality & Technical AgreementsICH E6(R3) gap assessmentRegulatory submissions & advisory

Regulatory Frameworks Bright Works In

Bright Gnanaselvam has direct working experience across these regulatory frameworks — built through audits, submissions, and advisory engagements, not desk research.

TGA

Australia

Therapeutic Goods Administration — manufacturing licences, GMP clearances, and audit support

APVMA

Australia

Australian Pesticides and Veterinary Medicines Authority — GMP compliance for veterinary and agricultural chemical manufacturers

FDA

United States

Food & Drug Administration — 21 CFR 210/211, PAI preparation, warning letter response

EU GMP

European Union

EMA and national competent authorities — Annex 1, 11, 15, and 16 compliance

NMPA

China

National Medical Products Administration — GMP certification and China market entry

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.