1. OUR SERVICES Who We Are
V2 Bio-Consulting, Inc. is a specialized
consultancy providing GxP and
operational expertise to BioPharma, Chemical,
and Industrial Companies.
Headquartered in the San Francisco Bay Area,
V2 seeks to address the special needs of its
clients from compliant strategic planning to
tactical management.
Our team of experienced Project Management,
Quality, Engineering, Construction Management,
Start-up, Commissioning, Validation and
Operations professionals provide The Owner’s
Perspective (“TOP”) Consulting Services on
multiple projects worldwide. Many of V2's TOP
Consultants have worked in positions of
managerial responsibility at successful
BioPharma, Chemical, and Industrial
Companies. Together we extend your
management capabilities by partnering our
specialists with your management and project
teams to augment and optimize your operational
or project performance.
Quality (GxP)
 Quality Assurance Systems
 Implementation & Management
 SOP Development
 GxP Auditing
 Regulatory Affairs
 Document Management
 EDMS System Implementation
 SharePoint
 Clinical Quality Management
Validation
 Quality
 Engineering
 Processes
 IT
Manufacturing Operations Support
 Engineering Service
 Facility Compliance Management
 Manufacturing Services
 Supply Chain
 Technical Operations
Business Operations
 Strategic Management
 Project Management
 Budget, Scope, Schedule
 Forecasting
 Vendor Management
 Communications and Team Solutions
Contact Info:
Email: services@v2bio.com
Phone: (925) 890-0255

2. OUR SERVICES (Cont) Our Clients
 Abgenix
 ADC Therapeutics
 Amylin
 Aradigm
 Avalanche
 Bayer Health Care
 Biocine SpA
 BioMarin
 Bio-Houston
 Cetus
 Chiron
 CMC Biologics
 Connectics
 Coopervision
 Dynavax
 Exelexis
 Genentech
 Ocular Sciences
 Gilead Sciences
 Heron
 J R Bioscience
 Kaketsuken
 McKesson
 Menarini Ricerche SpA
 Nektar
 Novartis
 VaxGen
 Protein Design Labs
 StemCentrx
 SteadyMed
 Sutro Bio
 Tanox, Inc
 Transcept
 Versartis
 Zogenix
 Zozano
Process Engineering
 Conceptual, preliminary and detailed designs
and construction, installation and
commissioning for GMP facilities
 Develop GMP documentation for
manufacturing and validation including
SOPs, BPRs, commissioning plans
 Develop project drawings including block
flow diagrams, process flow diagrams with
material and energy balances and piping and
instrumentation diagrams
Tech Transfer
 Correlating technical, marketing, and
regulatory requirements
 Monitoring technological innovation
 Economic analysis of process stages
 Managing analytical development, method
comparability and transfer studies, stability
and data validation studies
 Sourcing of raw materials (supply chain
management)
 Auditing and training for regulatory
inspections
Design and Construction
 URS and BOD Development
 Conceptual Facility Design and Layout
 Conceptual Budget and Schedule
 Construction Management
 FAT and SAT
Analytical Services
 Write and/or review SOPs/test methods and
validation/qualification protocols and reports
to support GMP testing
 Manage contract laboratories
 Provide guidance for method development
and product characterization
 Write and/or review analytical CMC and
nonclinical sections of regulatory
submissions, including CTDs (NDAs), INDs,
annual updates, and amendments