Pyxa Solutions is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs. Pyxa was founded in 2012 to provide our clients a refreshing consulting experience, through engagement with experienced industry leaders and consultants by delivery of high-quality deliverables and unique services. Pyxa is managed by a team of three seasoned partners with prior blended expertise in industry and management consulting.

1. Pyxa
Solu*ons,
LLC
COMPANY
OVERVIEW

2. A
BOUTIQUE
PROFESSIONAL
SERVICES
COMPANY
FOCUSED
ON
R&D
DELIVERY
WITH A SPECIALTY IN CROSS-FUNCTIONAL R&D
SERVICES AND SOLUTIONS FOR THE
PHARMACEUTICAL, BIOTECH AND MEDICAL
DEVICE INDUSTRIES

3. 3
FOUNDATION
9/24/16
TRANSFORM.
INNOVATE.
DELIVER.
PYXA
WAS
FOUNDED
IN
2012,
WITH
HEADQUARTERS
IN
THE
GREATER
PHILADELPHIA
AREA

4. 4
OVERVIEW
Pyxa
SoluDons
is
comprised
of
a
dynamic
team
of
management
consultants
and
R&D
subject
maTer
experts
specializing
in
cross-­‐
funcDonal
R&D
delivery
stemming
from
acDviDes
led
by
Regulatory
Affairs
9/24/16
Delivering
over
100+
engagements
In
over
40
companies,
Pyxa
offers
robust
professional
services
in
strategic
and
operaDonal
business
and
technology
soluDons
for
the
PharmaceuDcal,
Biotech
and
Medical
Device
industries
Our
operaDonal,
strategic,
consulDng
and
technology
services
span
across
R&D
with
a
focus
on
all
regulatory
specialDes
within
and
across
the
enDre
product
lifecycle,
for
both
major
and
emerging
markets
R&D
DELIVERY
WITH
A
SPECIALTY
IN
CROSS-­‐FUNCTIONAL
SERVICES

5. 5
DRIVING
VALUE
9/24/16
We
provide
regulatory
systems
and
project
management
exper*se
to
enable
organiza*ons
to
deliver
on
their
goals
and
jus*fy
investment
in
end-­‐
to-­‐end
regulatory
informa*on
management
by
increasing
strategic
delivery
while
reducing
commodity
tasks
We
ac*vely
help
organiza*ons
improve
their
R&D
performance
through
organiza*onal
analysis,
recommenda*ons,
development
of
improvement
plans
and
implementa*on
of
robust
solu*ons
that
are
scalable
and
adaptable
to
the
changing
regulatory
environment
We
evaluate
organiza*ons
holis*cally,
across
all
of
the
departments
involved
in
inpuVng
or
consuming
regulatory
data
to
achieve
significant
and
measurable
improvements
in
cost,
quality,
compliance
and
*me-­‐to-­‐market.

6. 9/24/16
6
PRACTICE
AREAS
OPERATIONS
STRATEGY
CONSULTING
TECHNOLOGY

7. 9/24/16
7
PRACTICE
AREAS
STRATEGY
R&D
STRATEGIC
SERVICES
Product
Development
&
Planning
Global
Labeling
&
Regulatory
Strategy
Technical
PM
(e.g.
Labeling,
Submissions)
Data
/
Informa*on
Governance
&
Strategy
Risk
Management
and
Compliance
Informa*on
Management

8. 9/24/16
8
STRATEGIC
SERVICES
Product
Development
&
Planning
Pre-­‐IND/CTA
Leading
Global
R&D
Product
Strategy
Global
Dossier
Strategy
Core
submission
package
Simultaneous
&
strategic
global
filings
Post-­‐Marke*ng
IND/CTA
&
Marke*ng
Applica*on
Drug
Product/Substance
InformaDon
Maintenance
post-­‐submission
Briefing
Document
ScienDfic
Advice
Global
Filing
Strategies
IteraDons
New
indicaDons
Label
updates
CMC
changes
New
markets
RegistraDon
Management
PromoDonal
materials
management
IB,
Protocol,
CSRs
&
Clinical
Summaries
Pre-­‐clinical
Reports
and
Summaries
Acquisi*on

9. 9/24/16
9
STRATEGIC
SERVICES
Global
Labeling
&
Regulatory
Strategy
One
Stop
Shop
for
all
Global
Labeling
and
Regulatory
Strategy
Services
Efficient
Global
Labeling
Process
that
enables
monitoring,
tracking
and
repor*ng
of
labels
from
crea*on
of
the
Company
Core
Data
Sheet
through
to
implementa*on
to
Local
Labels
and
finally
hand-­‐
off
for
Artwork.
Labeling
Opera*ons
Structured
Product
Labeling
(SPL)
Management
of
Drug
LisDngs
Data
and
Document
MigraDon
/
Management
System
Requirements
Labeling
Strategy
Full
outsource
global
labeling
support
for
Label
Management
Drug
Development
and
Post-­‐markeDng
Labeling
Strategy
Compliance
Metrics,
Tracking,
ReporDng,
Standards,
Templates,
Global
RegulaDons
/
Policies
Organiza*on
Governance,
Process,
Training,
FTE
Analysis,
OrganizaDon
Structure,
Design
and
OpDmizaDon
New
Legisla*on
eXtended
EudraVigilance
Medicinal
Product
DicDonary
(XEVMPD)
IdenDficaDon
of
Medicinal
Products
(IDMP)

10. 9/24/16
10
STRATEGIC
SERVICES
Technical
PM
(e.g.
Labeling,
Submissions)
Pyxa
provides
technical
project
and
program
management
to
ensure
accurate
and
quality
deliverables
Providing
Technical
Project
Management
Support
on
a
variety
of
cross-­‐func*onal
R&D
Ini*a*ves
Product
strategy
Label
Alignment
System
implementa*on
Standards
Process
Best
Prac*ce
Gap
Analysis

11. 9/24/16
11
STRATEGIC
SERVICES
Risk
Management
and
Compliance
Developing,
policies
or
SOPs
within
a
func*on
or
cross-­‐
func*onally
Communica*ng,
Implemen*ng
and
training
func*ons
on
new
Regula*ons
Founda*onal
Risk
Management
Assessments
Developing
and
implemen*ng
compliance
and
value
tracking
and
repor*ng
Pyxa’s
broad
and
diverse
range
of
services
enhance
compliance
and
aid
in
risk
management
and
mi*ga*on
Closed-­‐loop
between
change
control
and
regulatory
submissions

12. 9/24/16
12
STRATEGIC
SERVICES
Data
/
Informa*on
Governance
&
Strategy
Leverage
data
to
improve
processes
Transi*on
from
data
to
ac*onable
insights
Create
dynamic
data
models
that
are
easy
to
sustain
Increase
compliance
through
visibility
into
tangible
metrics
Improve
regulatory
intelligence
through
learning
and
data
sharing
Turn
sta*c
data
into
ac*onable
triggers
Reduce
costs
by
elimina*ng
data
redundancy,
commodity
tasks
&
varia*ons
Compliance
with
increased
data
repor*ng
requirements
Registra*on,
submission,
correspondence
&
commitment
tracking
Cross-­‐func*onal
data
/
informa*on
governance
and
management

13. 9/24/16
13
STRATEGIC
SERVICES
Informa*on
Management
Business
process-­‐based
applica*on
RIM
Strategy
&
Implementa*on
Challenge
IT
complexity
Data
simplifica*on
Connect
informa*on
flows
Shared
services
for
rou*ne
ac*vi*es
Mul*-­‐
func*onal
Approach
A
unique
holis*c
view
of
processes,
data
and
requirements
A
deep
understanding
of
the
informa*on
flows
between
Regulatory
Affairs
and
other
func*onal
areas
EVMPD eCTD
IDMP

14. 9/24/16
14
PRACTICE
AREAS
OPERATIONS
R&D
OPERATIONAL
SERVICES
Submission
Management
Document
Management
Publishing
Document
/
Data
Migra*on
Informa*on
Management
Systems

15. SUBMISSION-­‐READY
DOCUMENT
PREPARATION
Ensure
compliance
with
appropriate
ICH,
eCTD,
paper,
and
regional
guidance's
PROJECT
MANAGEMENT
FOR
GLOBAL
SUBMISSIONS
Manage
R&D
Submission
Team
and
Submission
for
all
major
and
minor
submissions
9/24/16
15
OPERATIONAL
SERVICES
SUCCESSFUL
MANAGEMENT
/
DELIVERY
OF
GLOBAL
LIFECYCLE
SUBMISSIONS
GLOBAL
SUBMISSION
GUIDANCE
INTERPRETATION
AND
DOCUMENT
AUTHORING
SUPPORT
Paper,
eCTD
and
NeeS
submission
compilaDon,
publishing
and
delivery
Submission
Management
PROVIDE
GUIDANCE
/
MANAGE
OUTSOURCING
OF
STRUCTURED
PRODUCT
LABELING
(SPL)
Content
of
Labeling,
Drug
LisDngs,
Establishment
RegistraDons

16. 9/24/16
16
OPERATIONAL
SERVICES
Publishing
SUCCESSFUL
LEADERSHIP/
PUBLISHING
OF
GLOBAL
SUBMISSIONS
DOCUMENT
QC
AND
READINESS
CROSS-­‐REFERENCING
AND
HYPERLINKING
STRATEGIES
CTD
GRANULARITY
GUIDANCE
ICH
AND
GLOBAL
DATA
STANDARDS
PAPER,
ELECTRONIC
AND
ECTD
AND
NEES

17. 9/24/16
17
OPERATIONAL
SERVICES
Document
Management
STRATEGIC
DOCUMENT
MANAGEMENT
FOR
ACQUISITIONS,
MERGERS,
DIVESTMENTS
AND
LITIGATIONS
DOCUMENT
STORAGE
STRUCTURES
AND
SUPPORT
(ARCHIVING
AND
DICTIONARY
MANAGEMENT)
NAMING
STANDARDS
AND
PLACEMENT
RULES
PROVIDE
ASSESSMENT
OF
TECHNOLOGY
SOLUTIONS
FOR
OPTIMAL
DOCUMENT
MANAGEMENT
LEGACY
DOCUMENT
MANAGEMENT,
(E.G.
GAP
ANALYSIS,
MIGRATION,
FORMATTING)

18. 9/24/16
18
OPERATIONAL
SERVICES
Document
/
Data
Migra*on
DATA
CLASSIFICATION
REGISTRATION
DATA
STANDARDS
AND
TEMPLATES
PROCESS
AND
TRAINING
CONCEPTUAL
DATA
MODELS

19. 9/24/16
19
OPERATIONAL
SERVICES
Informa*on
Management
Systems
CONTENT
MANAGEMENT
SYSTEMS
Veeva
(Vault)
Documentum
(EMC2)
FirstDoc
(CSC)
SharePoint
(Microsoh)
GLS
(Glemser)
PUBLISHING
SYSTEMS
Insight
Publisher
(Liquent)
eCTDXpress
(CSC)
Extedo
GlobalSubmit
Publish
DocuBridge
(Lorenz)
REGISTRATION
TRACKING
SYSTEMS
Insight
Manager
(Liquent)
TRS
Tracker
(CSC)
Trackwise
(Sparta
Systems)
ArisGlobal
DrugTrack
(Lorenz)
Vendor Neutral Product Selection
System Implementation, Maintenance and Upgrades
User Requirement Specifications (URS), Standards, Process and Training

20. 9/24/16
20
PRACTICE
AREAS
CONSULTING
R&D
CONSULTING
SERVICES
Business
Strategy
and
Planning
Organiza*onal
Transforma*on
Acquisi*ons
&
Post-­‐
Merger
Integra*on
Process
Excellence
Coaching
e-­‐Communica*ons
and
e-­‐Learning

21. 9/24/16
21
CONSULTING
SERVICES
Business
Strategy
and
Planning
Pyxa’s
focus
and
flexibility
provides
the
founda*onal
business
planning
services
essen*al
for
func*onal
or
enterprise-­‐wide
“commitment
and
alignment”
to
the
same
vision,
goals,
*melines
and
objec*ves
Pyxa’s
approach
spurs
collabora*on
and
brainstorming
across
func*ons,
and
across
organiza*ons,
encouraging
stakeholders
to
think
beyond
the
“status
quo”
and
put
equal
emphasis
on
short
term,
as
well
as,
long
term
goals
/
roadmap
Pyxa’s
broad
range
of
flexible
strategic
services
aid
clients
in
defining,
op*mizing
or
refining
their
func*onal
strategic
plans
accoun*ng
for
market-­‐driven
pressures,
such
as
globaliza*on
Cross-­‐Func*onal
R&D
Delivery

22. 9/24/16
22
All
organiza*on
transforma*on
deliverables
are
designed
in
alignment
with
the
func*onal
and
enterprise
wide
strategic
objec*ves
to
achieve
measurable
improvements
in
cost,
quality
and
*me-­‐to-­‐market
Pyxa
provides
systema*c
assessment
of
the
organiza*on,
detailed
modeling
(if
needed),
and
detailed
recommenda*ons
based
on
solid
analysis
and
future
projec*ons
Pyxa’s
business
transforma*on
ini*a*ves
include
developing
business
cases,
governance
models,
organiza*onal
surveys
and
assessments,
business
modeling,
skills
and
gaps
assessments
and
func*onal
org
design
CONSULTING
SERVICES
Strategic
&
Cost
Effec*ve
Organiza*ons
Organiza*onal
Transforma*on

23. 9/24/16
23
Pyxa
is
sensi*ve
to
internal
poli*cs
and
mo*va*on,
and
works
collabora*vely
across
all
func*ons
of
the
organiza*on,
from
Program
Management,
HR,
R&D,
Commercial,
IT
and
any
others
involved
in
the
integra*on
effort
Pyxa
manages
all
aspects
of
the
integra*on,
including
but
not
limited
to,
the
PMO
office
and
Change
Management
effec*vely
integra*ng
People,
Process
and
Technology
Pyxa
offers
end-­‐to-­‐end
program
management
for
acquisi*ons
and
post-­‐merger
integra*on
support
Integra*ng
People,
Process
and
Technology
CONSULTING
SERVICES
Acquisi*ons
&
Post-­‐
Merger
Integra*on

24. 9/24/16
24
We
develop
change
management,
communica*on,
training
(class
room
or
e-­‐learning)
and
implementa*on
plans
and
materials
to
support
the
successful
rollout
of
the
process
We
assess
the
“As-­‐Is”
state
in
a
quick
and
efficient
manner,
iden*fying
areas
of
weakness,
risks
and
gaps.
We
work
cross-­‐
func*onally
to
develop
the
“To-­‐Be”
state,
ensuring
alignment
and
endorsement
across
the
respec*ve
func*ons
Pyxa
offers
a
streamlined
and
holis*c
approach
to
cross-­‐
func*onal
R&D
process
development
and
op*miza*on,
to
enhance
opera*ons
and
ensure
compliance
Effec*ve
and
Efficient
Opera*ons
CONSULTING
SERVICES
Process
Excellence

25. 9/24/16
25
We
can
tailor
the
use
of
anima*on,
interac*vity,
audio,
and
video
to
suit
your
par*cular
learning
or
communica*on
needs
Through
our
exper*se
in
R&D
and
Ar*culate
Storyline,
we
can
create
new
eLearning
content
or
re-­‐purpose
your
exis*ng
content.
The
content
can
be
run
through
our
Learning
Management
System
(LMS),
or
through
any
3rd
party
LMS
Pyxa
specializes
in
developing
cost-­‐effec*ve,
yet
highly
engaging,
custom
content
and
online
courseware
and
communica*ons
Unified
Messaging
for
Streamlined
Opera*ons
CONSULTING
SERVICES
e-­‐Communica*ons
and
e-­‐Learning

26. 9/24/16
26
Coaching
CONSULTING
SERVICES
Pyxa
offers
a
blend
of
coaching
services
to
aid
organiza*ons
in
developing,
enhancing
and
progressing
internal
strategic
capabili*es
for
cross-­‐func*onal
collabora*ons,
advancement
in
leadership
abili*es,
streamlining
opera*ons
and
more.
These
services
vary
from
1:1
support
to
group
workshops
and
seminars.
Business
Process
Excellence
Change
Management
Leadership
Training

27. 9/24/16
27
PRACTICE
AREAS
R&D
TECHNOLOGY
SERVICES
TECHNOLOGY
Business
Case
Strategic
Planning
Opera*onal
Excellence

28. 9/24/16
28
TECHNOLOGY
SERVICES
BUSINESS
CASE
IT
system
jus*fica*on
for
new
or
replacement
systems
(ROI)
System
assessment
vs.
func*onal
and/or
regulatory
requirements
NEW
SYSTEM
DESIGN
AND
BUILD
CUSTOM
VS.
OFF-­‐THE-­‐SHELF
SOLUTIONS
JUSTIFICATION AND VALUE
PROPOSITION FOR
TECHNOLOGY NEEDS

29. 9/24/16
29
TECHNOLOGY
SERVICES
STRATEGIC
PLANNING
Pyxa
partners
with
clients
to
develop
sustainable
strategies,
technology
roadmaps
and
systems
for
the
management
of
regulatory-­‐focused
content
throughout
the
product
lifecycle.
We
bring
deep
exper*se
in
business
strategy,
opera*onal
transforma*on
and
technology
to
deliver
solu*ons
that
creates
measurable
business
value
and
jus*fies
technology
spend.
STRATEGIC INNOVATIVE R&D
SOLUTIONS DEVELOPMENT
AND IMPLEMENTATION
INNOVATING
TECHNOLOGIES
AND
BEING
EARLIER
ADOPTERS
LEADING
ADVANCEMENTS
WITHIN
THE
INDUSTRY
MOBILE
INTEGRATION
STRATEGY
AND
DESIGN

30. 9/24/16
30
TECHNOLOGY
SERVICES
OPERATIONAL
EXCELLENCE
Cross-­‐func*onal
data
governance,
analysis
&
mapping
Source
system
integra*on
and
roadmap
Enterprise
architecture
and
governance
Opera*on
IT
plan
development
Implementa*on
plans
Informa*on
architecture
/
requirements
assessment
CONNECTING
INFORMATION
FLOWS
AND
DATA
KEEPING
PROCESSES
AND
SYSTEMS
SIMPLE
IMPLEMENTATION AND
OPERATIONAL PLANNING FOR
LONG TERM SUCCESS

31. 9/24/16
31
WHY
PYXA?
COLLABORATE
&
LISTEN
PROBLEM
SOLVE
&
PLAN
FLEXIBLE
INNOVATE
Pyxa
is
managed
by
a
blended
team
of
industry
experts
and
management
consultants
We
listen
to
our
clients
needs
and
collaborate
to
ensure
alignment
throughout
the
engagement
We
solve
complex
problems
with
ac*onable
plans.
We
deliver
QUALITY
projects
ON
TIME
and
ON
BUDGET
Our
flexible
approach
and
experience
in
iden*fying
and
implemen*ng
solu*ons
allows
us
to
respond
to
a
client’s
changing
needs
INDUSTRY
EXPERTS
We
innovate
and
provide
a
framework
for
integra*ng
and
bridging
knowledge
across
mul*ple
technologies
and
thought
leaders

32. Contact
US
INFO@PYXASOLUTIONS.COM