Pharmaceutical Serialization Strategic Planning Guide

California 2015 Serialization & e-Pedigree:
Strategic Planning
A Road Map to Compliance & Realizing Business Value
Michael Stewart
Strategic Business Planning
Track & Trace Projects
PharmTech, Inc.
14048 Petronella Drive
Suite 201
Libertyville, IL 60048
(847) 281-8924 direct
(815) 403-8425 cell
MStewart@PharmTechInc.com

Table of Contents
Preface – aka Mike’s Soap Box .................................................................................................................3
Background ...............................................................................................................................................5
California Serialization & e-Pedigree Requirements.................................................................................7
Where do I start? ......................................................................................................................................8
Infrastructure & Processes........................................................................................................................9
Serialized Data Exchange ........................................................................................................................10
Solutions Provider Assessments .............................................................................................................11
Standardization.......................................................................................................................................12
Identifying Business Value ......................................................................................................................13
Business Value – Case 1 ......................................................................................................................14
Business Value – Case 2 ......................................................................................................................15
Conclusion...............................................................................................................................................16
About PharmTech ...................................................................................................................................17
About the Author: Michael Stewart........................................................................................................17

Preface – aka Mike’s Soap Box
Those that have heard me speak at industry events, private management workshops, or webinars know
that I am always asking “What can we do better?” The “We” is you, the client, and PharmTech. The
“What” is how you’re looking at your business and your project. It is what will turn this initiative, and
any future project, from a sunk cost to a strategic investment.
What I’m going to ask you to do in this strategy guide, written in a make-you-think cliff notes style, is to
step out of your comfort zone, especially when it comes to your mind set on business value. Included
are multiple questions that need to be thought through and answered and activities that need to be
performed, by internal staff or external resources. I will laundry list the various bullet pointed benefits
that everyone proclaims from serialization to derive ROI and business value. While others talk about
value in the ether, our engagements include actionable business value opportunities in our deliverables .
What I want you to do is take a step back and instead of looking at this initiative as specifically a
compliance project- a static, linear, regulatory challenge that has a beginning and end- I want you to
view it as an opportunity. I want you to be possibility driven and accept the breadth and depth of
choices out there.
Learn to see business opportunities that are there for the taking, but hidden just around-the-corner.
In this world there are two ways to view any situation that is perceived as difficult and requires
significant thought, time and resources. You can view it as problem-minded or opportunity-minded.
With a problem-minded approach, you see it as a static and linear issue that needs to be solved. You
believe that laser focus and getting to the end is doing the right thing, then cross it off the list. When you
are opportunity-minded, you view the situation from a 360 degrees perspective rather than as a linear
beginning to end. You begin to embrace the possibility of more: more outcomes, more benefits and
more value.
When you view situations in a linear perspective, a very straightforward, “this is what we need to do”, it
is like a horse with blinders on. You and your team are so focused on trying to see and solve what you
are trying to see and solve that at the end of the day you may have achieved the original end goal or
deliverable, but around you is a graveyard of opportunities missed. You win the battle and lose the war
Serialization, e-Pedigree and product life cycle projects have cross functional opportunities that many
times go missed because those involved do not see things in a 360 degrees perspective. They will miss
more value opportunities than they see and the results will be less than they could or should be.
You will see by a couple of the business value cases at the end, the mind shift for geometric revenue
growth and additional business value outside of the initial compliance scope that was a byproduct of
serialization and traceability planning. I could have easily shown examples of the traditional benefits
such as an internalization of serialization that led to a reduction in Days On Hand (DOH) inventory or

process efficiencies associated with applying GS1 standards to a pharmaceutical companies own
internal processes from ingredients and API’s to the distribution center workflow. That’s the easy stuff.
I’m going to show you how a project deemed to be a sunk-cost (compliance) can become a strategic
investment into the business that can drive millions in additional revenue and savings for your company.
Take that laser focus, that blinders-on focus, and shine that light through this new business value prism
to uncover all the hidden assets and hidden opportunities around this and future projects. There is little
to no additional cost involved in identifying these opportunities. All it takes is leadership and a shift from
being problem-focused to opportunity-focused.
With the immaturity in serialization in pharmaceuticals there are limited consulting and advisory
resources that have actually designed, planned, implemented and piloted traceability solutions,
PharmTech just happens to be one that has. There are two problems with most consultants. First, if
they are industry outsiders and journeymen, you are paying them to learn your business before they can
ever add value. Second, most bog you down in data and never provide action. They give information.
They should give advice. You should be receiving “Here’s what to do about a situation” and “Here’s
additional opportunities we uncovered in the process to be addressed now or later as you see fit.” Then
they should support it with facts. There is no benefit in giving you a data dump if you don’t know what
to do with it and why to do it.
The role of a consultant is to provide leadership, thus allowing stakeholders to take the next steps.
My role, and PharmTech’s role, is to connect the dots, to provide a road map and take you to the next
steps while identifying additional opportunities and mitigating potential risks.
God speed,
Strategic Business Planning &
Track & Trace Projects

Background
In 2004, the California Board of Pharmacy passed legislation that required that all pharmaceutical supply
chain parties, from manufacturer through pharmacy, be able to pass along an electronic pedigree that
would detail the movement and transfer of ownership of a pharmaceutical product at the smallest
saleable item level.
This mandate was to take effect January 1, 2007 and was later pushed back to 2009, then again to 2011
over production line and technology concerns. In 2008, after convening with industry stakeholders, the
California Legislature and the California Board of Pharmacy agreed to once again push back the effective
date of the legislation to January 1, 2015.
The pharmaceutical industry stakeholders involved unanimously agreed to accept the legislation with a
graduated implementation between January 1, 2015 and July 1, 2017. The expectation was that this
additional stay would allow the entire pharmaceutical supply chain (manufacturers, distributors,
pharmacies) enough time to work through the design, pilot and rollout of an interoperable e-Pedigree
solution in the safest and most cost-effective way for all parties involved.
The industry’s reaction and activities since the extension of the California mandates deadline for e-
Pedigree compliance has been mixed. A few of the major pharmaceutical companies and the “Big 3”
distributors (Cardinal Health, AmerisourceBergen, McKesson) took a leadership role and began planning,
designing and piloting possible serialization and e-Pedigree solutions. Since there was no industry
consensus as to technology, standards, data carriers and capabilities downstream these have been
accomplished with varied levels of success.
Meanwhile, other industry participants have sat on the sidelines looking for either a mandate from the
FDA requiring the same requirements as California or potentially usurping those requirements or have
had a wait-and-see position. Companies have chosen to wait for many reasons, but they boil down to
two. The first wait-and-see position derives from the idea that with the very real challenges inherent in
a supply chain wide initiative such as serialization and e-Pedigree, that California may yet again push
back the deadline. A second position stems from the idea that “Pioneers get arrows.” This means that
the first-movers, namely large Pharma, have the budget and resources to pilot and work through what
the eventual solution would be. The companies that delayed decided they either could not afford or are
not willing to absorb these trial and error costs.
Many other large and mid-sized pharmaceutical companies simply did not want to lay out the capital
and deploy resources for a large project such as serialization with legitimate concerns surrounding:
• Extension of the California effective date beyond 2015
• Uncertain technology
• Immature market and lack of proven technical resources
• Potential change to mandates by the FDA
• Evolving ex-US serialization and authentication requirements

We are now less than three years away from the California serialization and e-Pedigree mandates
coming into effect. The wishful thinking around the mandates getting delayed again or a “silver bullet”
plug-and-play solution to solve the technology interoperability concerns have not arrived. It is time for
all stakeholders to develop their strategic business plan and road map to implementation for California
2015 compliance.
PharmTech, Inc. has been leading the Track & Trace conversation, planning and piloting solutions with a
top 10 pharmaceutical manufacturer and others in the industry since 2007. In this strategic planning
guide I will share our learning curve and provide the framework for internal team and management
conversations around developing the strategic business plan for your company serialization and e-
Pedigree initiative.
Due to the varied and evolving international mandates surrounding labeling, serialization,
authentication, diversion and counterfeits, most pharmaceutical manufacturers have a handful of one-
offs and independent packaging and tracking solutions out there to address the concerns of a specific
market. What they have found is that this has become cumbersome and costly to the company and
opens the doors to more problems than solutions long term. In light of developing a California
serialization and e-Pedigree solution, todays manufacturers are looking at a holistic solution that is
seamlessly integrating both US and ex-US distribution.
The PharmTech California 2015 Serialization Strategy Guide is designed to lead the conversation and
incorporate more than just what solution providers to choose. When you look at a Track & Trace project
you need to view it not as a compliance project. View this as the infancy stage of building what will
become a legacy system within your organization that will deliver millions of dollars of tangible and
intangible benefits and efficiencies to the company, the people and the processes.
It is more manageable and prudent to plan and design a traceability system that can derive these
benefits for the company and various functions within the organization when you plan for all the ways
that you can use this new data that is being generated, both internally and externally.
For those manufacturers and distributors that have already installed a serialization and e-Pedigree
solution, this guide will provide value as a brief audit to ensure that the “i’s” have been dotted and the
“t’s” have been crossed. In engagements where pharmaceutical companies have serialized their lines,
PharmTech has then been brought in to develop the strategy behind “What can we do with this
information/solution to…increase revenue, improve adherence, gain dispenser loyalty, identify
efficiencies, etc…” There is value included here from those just starting strategy formulation and
defining requirements to those asking “How do we leverage the system we have?”

California Serialization & e-Pedigree Requirements
In a very simplistic fashion, below are the highlights of the SB 1307 & SB 1476 California requirements.
• Item level serialization at the smallest package level distributed by the manufacturer, received
and distributed by the wholesaler and received by the pharmacy or final dispenser
• Electronic pedigree, passed in interoperable format for each transaction of ownership change
• 50% of a manufacturers products by Jan. 1, 2015
• 100% of a manufacturers products by Jan. 1, 2016
• Wholesalers and re-packagers must accept and forward products with e-Pedigree by July 1,
2016
• Pharmacy and pharmacy warehouses must accept and pass e-Pedigree by July 1, 2017
• Penalties up to $5,000 per occurrence (each individual saleable unit is an occurrence)
The amended California State Bill 1307 (8/20/2008) can be found at:
ftp://leginfo.ca.gov/pub/07-08/bill/sen/sb_1301-1350/sb_1307_cfa_20080820_172325_sen_floor.html
A summary with definitions of key terms for State Bill 1476 (defining e-Pedigree) is available at:
http://www.pharmacy.ca.gov/laws_regs/e_pedigree_laws_summary.pdf
Additional material, including an extensive Q&A is available through the California Board of Pharmacy
site at:
http://www.pharmacy.ca.gov/about/e_pedigree_laws.shtml
From our experience, the largest challenge is not in the item level serialization component, rather in
achieving interoperable data exchange and continuity among multiple ERP systems, trading partners,
and business applications from the pharmaceutical manufacturer all the way downstream to the
pharmacy/clinic, all the while maintaining 100% data integrity. If even one event or transaction is
missed, the entire chain of custody for that item/case/pallet has been compromised and broken even if
there has been no diversion or foul play.

Where do I start?
Great question, I’m glad you asked.
In order to map how to get where you want to go, you have to know where you’re starting from.
In taking that first step into developing your strategic business plan you must define your “as-is” state.
These are the activities that highlight the existing infrastructure, product flow from manufacturing line
to final dispense and an understanding of how the company conducts business now and how that
strategy or business model is expected to change going forward.
Typical activities involve:
• Process mapping
• Gap analysis
• Current/Future state evaluation
• Business process analysis
• Review of commercial relationships (contract manufacturing, contract packaging)
• Analysis of market requirements, both US and ex-US
• Impact analysis
• Long term planning and forecasting
With a solid understanding of your base line it is time to move forward and compare the current state
(as-is) to your future state (wish-to-be).
By taking the time upfront to fully define the processes, movement and strategy of your company and
products throughout the supply chain it is easier to more clearly identify business value opportunities
that exist and red circle the areas that changes or upgrades need to be made going forward.
Strategy
Process Mapping
Document Current State
Commercial Relationships
Gap Analysis
Impact Analysis
Budget
Planning
User Requirements
Functional Requirements
Develop Use Cases
Technical Architecture
Develop Future State
Business Value Propositions
Solution Provider Assessment
Implementation
Installation
Standards Conversion
Training
Internal Test & Validation
Trading Partner Integration
Piloting

Infrastructure & Processes
An extensive review of the existing infrastructure and processes can create decision paths to guide the
project management and ensure that the correct path is chosen from start to finish.
When evaluating infrastructure you want to consider not only the technological areas, but those
associated with manufacturing, packaging and distribution as well.
An “as-is” versus “wish-to-be” infrastructure review should include discussion around;
• Legacy Systems
o Enterprise Resource Planning (ERP)
o Manufacturing Execution Systems (MES)
o Warehouse Management System (WMS)
• New Hardware
o Packaging and Printing; line and off-line
o Edge devices
o Vision systems
o RFID readers
• New Software
o Label management systems
o Reports, alerts and dashboards
o Policy based and user defined business rules
o EPCIS and central repository capabilities
o Serial number generation & management
o Business Intelligence tools (BI); current and future use
o Business Activity Monitoring (BAM); current and future use
• Implementation Strategy
o Manufacturing line considerations (new or retrofit)
o Line efficiency impact of serialization
o System validation requirements
o Hierarchy
o Gating
o Aggregation
o Master Data Management
• Tactical Considerations
o Exception handling
o User requirements & Functional requirements
o Process Workflows
A clear understanding of what your assets are and the processes that get your product manufactured,
packaged and distributed is instrumental in order to identify where the gaps are that need to be filled.

Serialized Data Exchange
In our experience, the line serialization, although a significant investment, is the less strategically taxing
component of the requirements. The larger challenge comes into play when you have multiple parties,
internal and external, and multiple technology platforms, internal and external, that require the
exchange of serialized data.
After a review of your internal infrastructure capabilities and processes, your team is now ready to ask
the questions that will help define the IT activities and needs.
Examples of the questions that need to be addressed are:
• Technology
o Does the technology team understand the standards (GS1 or other) that our systems
need to support? Is it capable of supporting multiple standards until they are merged?
o Has the technology team identified and coded internal and external product movement
events for EPCIS?
o Should we avoid integrating with any existing systems because there are plans to
replace the existing legacy systems in the next 3-5 years (i.e. ERP, WMS, MES)?
o How will we respond to e-Pedigree and supply chain queries?
• Processes
o What is our intent to aggregate product into hierarchies?
o Will each hierarchy be with the same data carrier or will it vary by item, case & pallet?
o How are exceptions to be managed internally? Externally?
o Will our serial numbers be managed at a site level, enterprise level or global repository?
Why?
o How will we provision serial numbers? Will our serial numbers be randomized? Why?
o What do we do with unused, yet distributed serial numbers?
o How will we handle serial number commissioning, aggregation, disaggregation and
decommissioning reporting?
• Relationships
o Have we identified all parties that we need to exchange serialized data with?
o Have we decided how we would like to receive serialized data from trading partners,
TPCM and TPCP?
o Have our trading partners decided how they would like to receive serialized data?
o How will data share and pedigree requirements differ between distribution options?
o How will we manage differing customer requirements in serialization?
As you can see, there is more to serialization than just generating a number and slapping a label on it.
The greatest leg work is in defining what data is generated, where it is to be sent, how it will be used,
how it will be sent, how it will be received and how all of this can be accomplished through multiple and
varied technological platforms.

Solutions Provider Assessments
There are two schools of thought when it comes to the assessment and selection of the solution
provider(s) in serialization and e-Pedigree projects.
The first is the “parade” approach. With this approach the stakeholders march in solution provider after
solution provider early in the process to hear about how their wares will solve every imaginable business
problem that the client has. After a few, they tend to blend together as they all say “We can do that
too.” This is not a slight on any solution provider. It’s their sales process.
Why this process is not effective is twofold. First, it is inefficient. It is a huge waste of time for the
stakeholders and the solutions provider as neither knows in advance of the meeting if there is a fit given
the value opportunities uncovered, markets that products are sold in, existing infrastructure, user
requirements, functional requirements, budgetary considerations etc… It’s an approach of throwing
stuff at the wall and hoping something good sticks- by both parties. If the right things are said it leads to
the “silver bullet” mind set where one can be deluded into thinking there is one magic solution. Second,
of course you will hear that the solution providers system can do anything you want; a) they have a
captive audience and b) they only have one arrow in their quiver (their solution).
Perhaps I’m being a little hard on the providers. Let me retrace my steps. All of the providers available
have excellent solutions. The difficulty is in ensuring they are a match based on what your specific
company requires: capabilities, functionalities, cost considerations, impact to existing processes and
their ability to deliver on existing and proposed strategic solutions that were defined in your early
strategic business planning.
The second approach is to bring in the solutions providers after the processes have been mapped,
impact has been determined, requirements have been defined, and the company has had the
opportunity, in advance, to vet and to compare and contrast the strengths and weaknesses of the
available solution providers before they meet.
As an example, PharmTech maintains an up to date proprietary Solution Provider Matrix for most of the
mainstream and upcoming serialization, manufacturing line, packaging line, middleware,
coding/marking, vision, e-Pedigree and BAM/BI providers available. The Matrix provides a high-level
assessment of their strengths, weaknesses, costs, interoperability with various IT and business
applications, service and support offerings, ideal client, sample of past engagements, and off-the-record
feedback. It is an example of a tool that leverages the time and resources of the project and our industry
experience.
Despite the marketing by many of the solution providers, there rarely is a case where a one-stop-shop is
the best choice when it comes to serialization and e-Pedigree, especially if the end solution is to address
both US and ex-US mandates now or in the future. A combination of solution providers is usually the
most beneficial. Performing this due diligence to ensure alignment with the strategic plan is crucial to
the success of the project and the company’s ability to leverage this infrastructure in the future.

Standardization
Although there is no required standard according to the California mandates or internationally, the
pharmaceutical industry consensus is moving forward with GS1 as the standard of choice. Long the
leading player in traceability within retail, GS1 standards allow for a uniform way to identify fixed data.
Through the years, various pharmaceutical mergers and acquisitions and an ever expanding breakdown
of product mix, has led to a substantial and growing mix of internal codes for product tracking purposes.
Further complicating the matter is that these codes may vary by distributor, geographical market sold in,
by packaging and by dosage just to name a few. GS1 standards harmonize this process by providing a
single reference that can be applied throughout the world.
In PharmTech’s consulting engagements, it would be an understatement to say that those in the
industry have underestimated the sheer volume of work and time it will require to assign GS1
identification numbers to product, places, trading partners, shipments and assets.
Below are the foundational GS1 identification types1
:
• GTIN Global Trade Item Number Trade Item
• SGTIN Serialized Trade Item Number Serialized Trade Item
• GLN Global Location Number Locations and Trading Partners
• SSCC Serial Shipping Container Code Logistics Unit
• GIAI Global Individual Asset Identifier Individual Asset
• GRAI Global Returnable Asset Identifier Returnable Assets
GS1 provides an international, cross-company, cross-industry and EDI qualifier standard.
Questions to consider are:
• Are we prepared for GS1 standardization and assigning serial numbers?
o GS1 company prefix, data carriers selected, hierarchies defined
• What resources are available to assign GTIN’s? How many will be required?
• What resources are available to track down the physical and accurate addresses for every
trading partner, supplier and customer to assign GLN’s?
• Will internal GLN’s be utilized for tracking of product movement from ingredients to dispense?
• When do I need this completed since it represents the backbone of the end solution?
1
A detailed explanation of and applicable use for each GS1 identifier is beyond the scope of this paper. Additional
information can be found at the GS1.org website in the Resources section.

Identifying Business Value
In the Background section it was mentioned that the serialization and e-Pedigree product traceability
solution should be viewed as more than just a compliance project and many pharmaceutical companies
have been less than motivated to embrace the implementation of track and trace solutions. That being
said, it would be naïve to miss the glaring reality that compliance is the current driver and motivation for
undertaking these projects.
Many Directors and VP’s within the industry embrace, as we do, that there are countless benefits to
come from serialization and the near real-time opportunity to view and dissect serialized product
movement data to capture business value, revenue enhancement and ROI. Even though the long term
business benefits to serialization have been proven in the retail, food and electronics industries over the
past 20 plus years, inclusion as a RFP (Request for Proposal) line item is mixed.
As with any endeavor, adding business value as a talking point muddies the water and turns into a
Missourian “Show me” debate that can derail the focus of getting the project funded.
The initial activities outlined in the “Where do I start?” section, the mapping of workflow processes
along with internal and downstream product flow, will open the door for identification of where
additional business value lies.
Project highlights from past engagements will give you a flavor for how compliance became a secondary
benefit and real, tangible, financial benefits were identified and captured on our way to compliance.
Below is a list of traditional advantages to a serialized product portfolio.
The case studies that follow will show how a change in mindset from fixing a compliance problem to
identifying business opportunities can open doors to creating value including increased market share
and improved adherence just name a few.
 Brand Protection
 Identification of counterfeiting and diversion
 Recall management
 Asset visibility, tracking & utilization
 Reverse logistics
 Issue resolution and opportunities
 Real time response with BAM
 Pedigree and authentication capture
 Leverage captured data for improvements in;
Sales & marketing
Inventory control
Logistics
Workflow processes
Cash-to-Cash/Cash-to-Order
Perfect order

Business Value – Case 1
With increasing costs of drug development, finding ways to boost market share of existing branded
drugs which have gone off patent was of prime concern, as branded drugs have higher premium than
competing generics.
Challenge:
• Flat sales and generic equivalents
• Current system too costly
• Need serialization compatibility
Scope of Work:
• System replacement
• Item level serialization
• Identify business value
Results:
Serialization mitigated future regulatory concerns
700 Clinic Pilot
Authentication achieved
Created an automated software for the dispenser that provided,
• Direct billing to Medicare
• Automated inventory management reduces over-stock/under-stock
• Dispense management system with patient and inventory interface
• Automated patient scheduling
• Direct Electronic Health Record (EHR) integration, HIPAA compliant
• Reduced customer service staff 40% at the manufacturer
3% increase in overall market share
Extensible to other products and divisions
Additional Value Identified:
During the initial strategic business planning PharmTech identified how the serialized data could be
managed at the clinic level to generate efficiencies for the clinics patient management, automated
inventory replenishment and billing directly to Medicare to avoid missed billing reimbursement for the
healthcare provider. This led to a 3% “overall” increase in market share from just 30% of the distribution
channel and the signing up of 20 additional clinics due to the practice improvement software developed.

Business Value – Case 2
Challenge:
Manufacturer needed to serialize self-injectable for California compliance.
Additional Value Identified:
During the Product Life Cycle process mapping PharmTech identified that the manufacturer was losing
opportunities in a self-injectable between Physician Recommendation & Decision Day (by patient) as
well as the time line between Prior Authorization (PA) & Benefit Verification (BV).
Business Value Highlights;
-Serialized the product line and piloted electronic data share of serialized information between partners
to ensure California serialization and e-Pedigree compliance
-Provided web based education and financial assistance to patient to accelerate Decision Day choice
-Integrated with EHR’s and Third Party Providers to remain HIPAA compliant
-Opt-in at clinic level by patients for manufacturer provided education, third party marketing and pre-
populated benefit forms for immediate benefit submission
-Decision Day to Prior Authorization goes from an “endless loop” to 20 minutes rather than 3-4 weeks
-Automated insurance Prior Authorization & Benefit Verification process reducing the decision from
“Prior Authorization to Decline to Submission to Benefit Verification and Approval” from 30-60 days to
72-96 hours
-Increased clinic and patient adherence
Physician
Recommendation
DecisionDay
Patient
PriorAuthorization
Insurance
Denial
BenefitVerification
Approval
Delivery
Adherence
Physician
Recommendation
DecisionDay
Patient
PriorAuthorization
Insurance
Denial
BenefitVerification
Approval
Delivery
Adherence
30-60 Day Cycle
4-6 Day Cycle

Conclusion
Undertaking or improving upon a serialization and e-Pedigree project is a daunting task. In order to
continually move forward and avoid the many potential pitfalls along the way it is imperative that you
and your team craft a road map to get you from the strategic business planning through the tactical
implementation phase.
Herein I have described the high level questioning and process analysis that can craft a strategy and
provide direction for your project. Like Alice in Wonderland’s rabbit-holes, answering one question
opens the door to many others.
If you have the time, training, and resources on staff to complete the strategy and project management
of your serialization and traceability initiative I encourage you and your team to begin/continue the
journey towards compliance and identification of additional benefits. If, on the other hand, your team
may require the guidance and leadership of track & trace consulting professionals that understand
pharmaceutical workflow processes, technology interoperability, regulatory packaging requirements
and can identify where the land mines are buried so you can avoid them, PharmTech or another
seasoned firm would be happy to assist.
One cautionary note, if you require serialization and e-Pedigree strategy or implementation project
management leadership, the amount of experienced and qualified traceability consulting resources is
slim and may dry up quickly as the mandates grow closer. Being proactive on contracting with a
knowledgeable firm and gaining access to their resources that are familiar with traceability will ensure
that you will not have to settle for what is available with less qualified consultants.
The clock is ticking and each day that passes is one day closer to the California mandates taking effect.
We wish you well in obtaining compliance and identifying business value along the way.

About PharmTech
PharmTech has a diverse 17 year background in Quality, IT, FDA compliance, manufacturing, workflow,
distribution center management and supply chain. We are positioned to understand the entire product
life cycle, how California regulations impact operations, and how to identify business value in the
processes to leverage the newly serialized infrastructure. The inclusion of business value into projects is
how we have always done business with our clients. This forward thinking leadership is the trait that is a
differentiator in PharmTech being selected for the pharmaceutical and biopharmaceutical projects we
undertake.
About the author: Michael Stewart
With a background in investment banking and long term financial planning, Michael
brings a unique perspective to the pharmaceutical industry. His approach of identifying
ROI and business value in Track & Trace, serialization and Life Cycle Management
projects turns these initiatives from a perceived cost into a strategic investment.
Michael is a successful and entrepreneurial senior sales and business development
executive with 18 years of experience in raising and deploying capital at regional and
national levels for established investment banks, major corporations, start-ups and
consulting organizations.
Mr. Stewart is a regular guest and speaker at industry events, has delivered educational workshops,
webinars to pharmaceutical executives and stakeholders, and authored white papers around topics
including; track & trace, supply chain optimization, pharmaceuticals, financial and sales & operations.
Michael and the PharmTech team are available for speaking engagements, private thought leadership
workshops, strategic business planning and project management for all areas of the product life cycle
that touches strategy, commercial opportunities, IT, manufacturing, packaging, supply chain and sales &
marketing.
You may contact Michael at:
(847) 281-8924 direct
(815) 403-8425 cell
MStewart@PharmTechInc.com

Pharmaceutical Serialization Strategic Planning Guide

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