Enterey Life Sciences Consulting founder Mike Ferletic former Ernst & Young Consulting felt he understood what the market was asking for -- Big 5 level consulting at an affordable cost to our clients. A Holistic Approach to Problem Solving Sustainable Results with True ROI Life Sciences Focused

1. Enterey Life Sciences
Consulting 2012
For Biotechnology | Pharmaceutical | Medical Device Manufacturing
© 2012 | All Rights Reserved.
No part of this document may be redistributed or
reproduced in any form or by any means, without
the prior written permission from Enterey, Inc.

2. Established in 2002, Enterey Life Sciences Consulting founder Mike Ferletic former Ernst &
Young Consulting felt he understood what the market was asking for -- Big 5 level consulting at
an affordable cost to our clients.
• Over 20 years of combined industry experience.
• Successfully worked with leading industry companies.
We’re passionate about our work, the industry we serve, and our clients. It is our goal to assist
emerging companies and proven thought leaders in their quest to bring life-changing products to
those in need. We believe our success comes only through yours and hope our innovative
solutions help you to continue your path of innovation.
World Class
Business Strategies and Best Practices Fit for You
Enterey Inc., © 2012 | Page 2

3. • Established in 2002
• Minority Owned
• Headquarters in Irvine, CA (“Representation in the Midwest”)
• Solutions that Exactly Meet Client Needs
• Experienced, Multi-Disciplinary Staff
• Integrating People, Process and Technology
• Integrated Services (“Tailored to Unique Client Needs”)
• Hands-On & Results-Oriented (“Tangible ROI”)
• Global Client Base & Delivery Capability
• Team Oriented (“Mentors / Trainers”)
• Focused on Strategic Partnerships
• Sustainable Knowledge Transfer
Professional Experts
Building a More Responsive Consulting Firm
Enterey Inc., © 2012 | Page 3

4. Life sciences thrive upon great minds, innovative ideas and cutting edge technology.
We make sure the path to market and day-to-day operations won’t distract your
organization from achieving its critical focus.
 We’re a Company Focused on You
to Help Save You Time
 Proven & Personalized Life Sciences
Expertise to Help Save You Energy
 We Streamline the Process
to Save You Money
Real Savings
Our Services Save Time, Energy and Money
Enterey Inc., © 2012 | Page 4

5. Our Methodology is to BLEND PEOPLE, PROCESS, and TECHNOLOGY
for better operations solutions.
Every company has its own mix of people, process and technology. True operational
excellence requires a balance of all three – our approach focuses on finding and creating
that unique balance for you.
 A Holistic Approach to Problem Solving
 Sustainable Results with True ROI
 Life Sciences Focused
PHARMA DIAGNOSTICS
BIOLOGICS MED
BIOTECH DEVICE
Enterey Inc., © 2012 | Page 5

6. Applying Enterey Methodology to a Enterey Approach:
Project: A company with heavily manual Assess the project impact on key stakeholders and
processes is looking for a technology end-to-end business processes, rather than simply
implementation to better operations with the process that the technology touches. Focus on
automated and streamlined scheduling system implementation while addressing people and
process to increase overall success. Ensure process
Notable Facts: integrates and optimizes the end-to-end business
Current company culture rewards hard processes without simply transferring inefficiencies
work but not efficiency. Employee to other processes
resistance to change is high
The Result:
A more effective, seamless implementation that
allows your team to focus on the next project or
initiative versus spending time tying up loose ends
that were not addressed in the original plan
Methodology to Projects
Applying the Methodology to a Project
Enterey Inc., © 2012 | Page 6

7. Applying Enterey Methodology to a Enterey Approach:
Strategy: A company is looking to High-level recommendation always considers
increase their clinical pipeline capacity implementation and any potential obstacles as part
and shorten their time to market by 50% of the overall strategy
over the next five years.
Strategy leverages industry best practices to
Notable Facts: address company specific needs versus assuming
Current manufacturing capability can’t that industry norms are relevant to every company.
support targeted 50% reduction in time to Our short-term plan for success includes support for
market. Growth will be achieved through long-term sustainability
acquisition not organically. Company has
limited experience with acquisitions The Result:
A clear, executable strategy that promotes
continuous improvement, and maximizes
return on investment
Methodology to Strategy
Applying the Methodology to a Strategy
Enterey Inc., © 2012 | Page 7

8. Clients
Focused on Building an Maintaining Trusting Relationships
Enterey Inc., © 2012 | Page 8

9. Biotech Manufacturer Pharma Manufacturer Device Manufacturer
People People People
Process Process Process
Tech Tech Tech
Employees: 245 Employees: 122 Employees: 356
No. of Facilities: 2 No. of Facilities:2 No. of Facilities: 3
Annual Sales: 66M Annual Sales: 27M Annual Sales: 110M
• Cost Reduction • Facility Startup • New Product Launch
• Inspection - OEM
Project Management Preparation • Process and
Enterey helped identify • Technology Transfer Development
headcount targets and • Training
operation efficiencies to Project Management • Lean and Six Sigma
support a 50% reduction in Enterey helped a leading • Manufacturing
cost per gram by project end. pharma company manage new
Performance goals were met facility construction, plant Project Management
with no impact to business commissioning, and Enterey worked with a global
operations. Programs for staff commercial product medical device manufacturer to
to improve and build skill sets manufacturing activities launch the design and manufacture
were increased and leading to successful State, of an infant medical device. After
opportunities for displaced FDA, and EMEA approvals the launch, Lean and Six Sigma
employees were made within the initial project methodologies were implemented
available. timeline. to reduce manufacturing costs.
Case Studies
Real Examples of Our Expertise
Strategy &
Risk Management
Solutions Enterey Inc., © 2012 | Page 9

10. Enterey offers expertise life sciences consulting across both process and system related
projects which enables us to build sustainable customized solutions for a wide range of needs -
such as/from strategic planning and implementation, specialized efforts such as clinical and
commercial facility start-ups, to business integration activities.
Areas of Focus
Regulatory,
Strategy & Technology &
Quality &
Risk Management Implementation
Compliance
Solutions Services
Consulting
Customized Solutions
We Offer Services that Help Organizations Succeed
Enterey Inc., © 2012 | Page 10

11. People • Business Process • Change Management
______________ Improvement (BPI)
• Decision Making
• Strategic Planning (PRO-Enterprise Management)
• Transition & Integrations • Quantitative Analysis
Process
______________ • Post Merger/Acquisition • Governance & Decision
Making
• Strategic Planning
• Risk Management/ Mitigation
• Workforce Development
Technology
______________
Strategy & Risk
Management
Blending People, Process, and Technology Across All Workstreams
Enterey Inc., © 2012 | Page 11

12. People • Program & Project • Software Selection
______________ Management
• Implementations
• Facility Start-up
• Systems Integrations
• Technology Transfer &
Process Commissioning • Training Programs
______________
Technology
______________
Technology &
Implementation
Blending People, Process, and Technology Across All Workstreams
Enterey Inc., © 2012 | Page 12

13. Quality Systems • Master Validation Plans
• CAPA • Process Validation
People
• Cleaning Validation
______________ • Discrepancy Management
& Investigations
• Change Management Inspection Readiness/ MGMT
• System Implementation • Gap Analysis
• Gap Remediation
Process • Gap Assessment
______________ • Metrics Development • Mock Audits
• Inspection Risk Prioritization
• Metrics Development
Validation
• Speaker Prep & Training
• Facility & Equipment
Qualification
Technology • Computer Systems/ Quality Risk Management
______________ Software Validation & • Program Development
Part 11 Compliance • Training
Regulatory, Quality
& Compliance
Blending People, Process, and Technology Across All Workstreams
Enterey Inc., © 2012 | Page 13

14. Telephone: 800-691-2349 Locations
Email: info@enterey.com Irvine | San Francisco | Ohio | Chicago
Website: www.enterey.com
Corporate Office Billing & Inquiries Address
9900 Irvine Center Drive, Suite 100 23052-H Alicia Pkwy, Suite 321
Irvine, CA 92618 Mission Viejo, CA 92692
800.691.2349
How Can We Help? Call Us
Enterey Inc., © 2012 | Page 14