Enterey Overview 2012 V5

© 2012 Enterey Inc.

B i o t e c h n o l o g y | P h a r m a c e u t i c a l | M e d i c a l D e v i c e

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© 2012

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Enterey Life Sciences, Inc.


Enterey Consulting was established and founded in 2002 by Mike

Ferletic formerly of Ernst & Young Consulting.

• 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.


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


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.

• Proven and personalized life sciences expertise.


Blending 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 and Agile approach to problem solving.

• Resulting in Sustainable Solution with a true ROI.



Focused on Building & Maintaining Trusting Relationships


Enterey offers expert life sciences consulting by providing services which cover the areas of strategic planning, technology and implementation to regulatory, quality and compliance projects.

• Strategy / Risk Management Solutions

• Technology & Implementation Services

• Regulatory, Quality & Compliance Consulting


Regulatory, Quality &

Compliance

Consulting

Technology &

Implementation

Services

Examples:

• Inspection Readiness/ Management

• Quality Systems

• Validation

• Quality Risk Management

Solutions Integrating

Four Service Areas

Examples:

• Program and Project Management

• Facility Start-up/ Technology Transfer &

Commissioning

• Software Selection and Implementation

• QES/MES Support and Program Dev.

• Training


Five Service Areas

Example:

• Business Process Improvement

• Transition & Integrations

• PRO Enterprise Management

• Change Management


Four Service Areas

Strategy & Risk

Services


Process Validation

Cleaning Validation

Change Management

Systems Implementation

Gap Analysis

Metrics Development

Facility & Equipment

Qualification

Computer Systems and

Softwaree Validation P 11

CAPA

Discrepancy Management

Gap Analysis/Remediation

Mock A&I, Inspection Risk

Metrics Development

Speaker Prep & Training


QMS, LIMS, LMS, ERP,

MRP, CRP, Validation

Technology

Commissioning

Software Selection

Software Implementation

Software Integration

Computer Systems and

Software Validation P 11

Gap Analysis/Remediation

Training

Facility Start-up

Technology Transfer

Program & Project

Management


BPI (Business Process

Improvement)

Governance & Decision

Making

Decision Making

(PRO-Enterprise Mgt.™)

Quantitative Analysis

Transition & Integrations

Strategic Planning

Operations & Compliance

Risk Management/Mitigation

Work Force Development

Change Management

Quality Culture


World-class business strategies and best practices fit for you

through a balance of people, process and technology

• Resource Training

• Change Management

• Leadership Development

• Strategic Planning/Decision Making

• Inspection Preparation

• Quality Assurance/Control

• GMP/FDA Regulatory

• ISO Certification

• Six Sigma & Lean Manufacturing

• Cost Reduction

• Information Technology

• Facility Start Up

• Technology Transfer

• MRP/ERP Conversions

PE

OP

LE

P

RO

CE

SS

T

EC

HN

OL

OG

Y


• Compliance

• Quality Systems

• Commissioning

• Inspection

Preparation

• Risk Management

• Facility Start-Up

• Facility Expansion


• Process Justification

• Validation

Quality Assurance Operations

• QMS

• LIMS

• LMS

• Software Validation

• ERP

• MRP

• CRP

• Software Validation

• Business Process

Improvement

• Metrics

• Operational Excellence

• Lean Manufacturing

• Six Sigma

• Kaizen Events

• Metrics

P e o p l e

P R O C E S S

T E C H N O L O G Y

World-class business

strategies & best practices,

finding balance between

people, process &

technology


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.

Biotech

Manufacturer

Pharmaceutical

Company

Employees: 122

No. of Facilities:2

Annual Sales: 27M

• Facility Startup

• Inspection

Preparation


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.

Device

Manufacturer

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


Enterey, Inc.

9900 Irvine Center Drive, Suite 100

Irvine, CA 92618

Sales: Rob Johnston, Director

(P): 800-691-2349

(F): 949-336-5201

(C):484-682-9004

Email: [email protected]


We’re a company focused on you!!

Documents

Enterey Overview 2012 V5