Committed to Excellence in Regulated Industries.

Delivers risk-based approach and audit-ready Validation and Quality Management strategies for the pharmaceutical and biotech industries.

Areas of Expertise

Who We Are?

VPath Consulting is a specialized professional boutique consulting firm dedicated to clients across Pharmaceutical and Biotechnology Industries. With a focus on quality, compliance, and operational excellence in alignment with ALCOA+ principles while implementing measures to producing documents right-the first time.

Together, we’ll pave the way for project success!
Learn More
  • Ongoing Support and Capital Projects
  • CQV Support: VMPs, Facility, Utility Systems and Equipment (FUSE) Impact Assessments, Protocol Development, Executions, Reports, Reviews/Approvals
  • Compliance Documentation: Development and Reviews of URSs, SOPs, Work Instructions, Batch Records, CAPAs, Deviations
  • Investigations and Root Cause Analysis
  • Remediations: Regulatory/Client responses, CAPA management
  • Training: GDP, GMP, CQV, Regulatory Inspection Readiness
  • Leadership and Coordination of Projects

Areas of Expertise

VPath Consulting Services delivers comprehensive Quality Management and Commissioning, Qualification, Validation (CQV) services across the Pharmaceutical and Biotechnology sectors. We provide support across Engineering, Technical Services, Process Development, Validation, and Quality functions. We are committed to ensuring quality, compliance, and operational excellence in alignment with ALCOA+ principles while implementing measures to producing documents right-the first time.

Facility / HVAC
Systems

Utility Systems

Equipment

Aseptic
Process

Quality Management
System / Remediation

Data
Integrity

Preparation/Review Of The Following:

SOP • URS • FRS • TM • VMP • C&Q
Validation • Quality System Documentation

VPath Consulting will ensure all Facility, Utility Systems, Equipment (FUSE) are qualified for their intended use and comply with regulatory requirements (e.g., Health Canada, FDA, EMA). Involvement: Design Review & URS Development, CQV activities, Cleanroom & APS Validation, Computer System Validation (CSV), Process Validation, and Training.

Quality support will ensure all activities from R&D to manufacturing are compliant and focused on Safety, Identity, Strength, Purity, Quality (SISPQ). Involvement: Quality Management System (QMS) Setup, Oversight of CQV, Batch Release & Product Quality, Regulatory Readiness, Training & Compliance Culture.

“At VPath Consulting, we believe success begins with commitment, trust, and expertise. Our mission is to listen closely to our clients, understand their unique needs, and deliver tailored solutions that drive results.”

Anita Koundakjian, P.Eng., Director, VPath Consulting

Client Success Examples

Each success story reflects our commitment to precision, partnership, and results.

Pharmaceutical
Manufacturer:

Led validation activities for Aseptic Manufacturing resulting in successful Health Canada inspection approval.

Tech transfer plan for a technology transfer between sites of same organization.

BioTech
Facility:

New CDMO Facility Capital Project at a Cell & Gene Therapy
• Owner Representative to assist with directing CQV activities.

Medical Device
Manufacturer:

Led validation activities resulting in successful European Medicines Agency inspection approval.

What’s New at VPath!

We’re expanding our service capabilities with enhanced support for Startup facilities – ensuring clients are inspection-ready the first time.

What’s New