enterey overview 2012 v6 tt august 2012 final blue background

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.

http://www.enterey.com/

World Class Business Strategies and Best Practices Fit for You

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.

Enterey Inc., © 2012 |


• 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



Real Savings Our Services Save Time, Energy and Money

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


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

BIOLOGICS

BIOTECH

PHARMA

MED

DEVICE

DIAGNOSTICS


Methodology to Projects Applying the Methodology to a Project

Enterey Approach:

Assess the project impact on key stakeholders and

end-to-end business processes, rather than simply

the process that the technology touches. Focus on

system implementation while addressing people and

process to increase overall success. Ensure process

integrates and optimizes the end-to-end business

processes without simply transferring inefficiencies

to other processes

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

Applying Enterey Methodology to a

Project: A company with heavily manual

processes is looking for a technology

implementation to better operations with

automated and streamlined scheduling

Notable Facts:

Current company culture rewards hard

work but not efficiency. Employee

resistance to change is high



Methodology to Strategy Applying the Methodology to a Strategy

Applying Enterey Methodology to a

Strategy: A company is looking to

increase their clinical pipeline capacity

and shorten their time to market by 50%

over the next five years.

Notable Facts:

Current manufacturing capability can’t

support targeted 50% reduction in time to

market. Growth will be achieved through

acquisition not organically. Company has

limited experience with acquisitions

Enterey Approach:

High-level recommendation always considers

implementation and any potential obstacles as part

of the overall strategy

Strategy leverages industry best practices to

address company specific needs versus assuming

that industry norms are relevant to every company.

Our short-term plan for success includes support for

long-term sustainability

The Result:

A clear, executable strategy that promotes

continuous improvement, and maximizes

return on investment



Clients Focused on Building an Maintaining Trusting Relationships



Case Studies

Employees: 245

No. of Facilities: 2

Annual Sales: 66M

• Cost Reduction

Project Management

Enterey helped identify

headcount targets and

operation efficiencies to

support a 50% reduction in

cost per gram by project end.

Performance goals were met

with no impact to business

operations. Programs for staff

to improve and build skill sets

were increased and

opportunities for displaced

employees were made

available.

Employees: 122

No. of Facilities:2

Annual Sales: 27M

• Facility Startup

• Inspection

Preparation

• Technology Transfer

Project Management

Enterey helped a leading

pharma company manage new

facility construction, plant

commissioning, and

commercial product

manufacturing activities

leading to successful State,

FDA, and EMEA approvals

within the initial project

timeline.

Employees: 356

No. of Facilities: 3

Annual Sales: 110M

• New Product Launch

- OEM

• Process and

Development

• Training

• Lean and Six Sigma

• Manufacturing

Project Management

Enterey worked with a global

medical device manufacturer to

launch the design and manufacture

of an infant medical device. After

the launch, Lean and Six Sigma

methodologies were implemented

to reduce manufacturing costs.

People

Process

Tech

People

Process

Tech

People

Process

Tech

Biotech Manufacturer Pharma Manufacturer Device Manufacturer

Real Examples of Our Expertise

Strategy &

Risk Management Solutions


Strategy & Risk Management

Solutions

Technology & Implementation

Services

Regulatory, Quality &

Compliance Consulting

Customized Solutions


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

We Offer Services that Help Organizations Succeed



Strategy & Risk Management


Blending People, Process, and Technology Across All Workstreams

• Change Management

• Decision Making

(PRO-Enterprise Management)

• Quantitative Analysis

• Governance & Decision

Making

• Risk Management/ Mitigation

• Business Process

Improvement (BPI)

• Strategic Planning

• Transition & Integrations

• Post Merger/Acquisition

• Strategic Planning

• Workforce Development

People

______________

Process ______________

Technology ______________


Technology & Implementation


• Program & Project

Management

• Facility Start-up

• Technology Transfer &

Commissioning


• Software Selection

• Implementations

• Systems Integrations

• Training Programs

People

______________

Process ______________



Regulatory, Quality & Compliance


Quality Systems

• CAPA

• Discrepancy Management

& Investigations

• Change Management

• System Implementation

• Gap Assessment

• Metrics Development

Validation

• Facility & Equipment

Qualification

• Computer Systems/

Software Validation &

Part 11 Compliance

• Master Validation Plans

• Process Validation

• Cleaning Validation

Inspection Readiness/ MGMT

• Gap Analysis

• Gap Remediation

• Mock Audits

• Inspection Risk Prioritization

• Metrics Development

• Speaker Prep & Training

Quality Risk Management

• Program Development

• Training


People

______________

Process ______________



800.691.2349 How Can We Help? Call Us

Telephone: 800-691-2349

Email: [email protected]

Website: www.enterey.com

Corporate Office

9900 Irvine Center Drive, Suite 100

Irvine, CA 92618


Locations

Irvine | San Francisco | Ohio | Chicago

Billing & Inquiries Address

23052-H Alicia Pkwy, Suite 321

Mission Viejo, CA 92692


enterey overview 2012 v6 tt august 2012 final blue background

Documents

enterey methodology

process notable facts

unique client

people andprocess

level consulting

mix of people

processes resistance

edge technology