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.

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OPTIMIZING BUSINESS PROCESSES TO DRIVE
EFFICIENT GLOBAL SUBMISSION MANAGEMENT
Ac6vi6es stemming from Regulatory Affairs tend to be cross-func6onal and
global in nature. Many organiza6ons struggle with achieving excellence,
reducing costs and increasing compliance due to lack of organiza6onal and
process efficiencies.
Several factors contribute to the complexity of Submission Management in a Pharmaceutical
Company. (1) While Submission Management is traditionally “owned” by Regulatory
Affairs, the content, data and infrastructure that support a Submission are owned by several
other functions. (2) Consistently changing global regulations require constant upkeep and
modification of business practices to ensure compliance. (3) Complex information landscape
necessitates the optimal use of resources to set in motion simultaneous global submissions.
To streamline the complex nature of Global Submission Management, Pharma must ensure
they establish a robust organizational foundation based on sound business processes.
Through these processes, roles and responsibilities are clearly defined, timelines for time-
sensitive activities are established, hand-offs from one activity to the other are articulated,
bottlenecks & risks are identified & mitigated and metrics & KPIs are put into motion to
track and report outcomes.
✔ Roles
✔ Responsibili6es
✔ Timelines
✔ Hand-off’s
✔ Repor6ng
✔ Metrics
✔ KPI’s
GAINING EFFICIENCIES WITH SOUND GLOBAL OPERATIONS
AND AN EFFECTIVE REGULATORY SUBMISSIONS PROCESS

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Establishing the processes may seem daunting and costly at first, but once the optimal
processes are in place, the long-term value, including increased compliance and overall cost
reduction will be felt and appreciated over years to come. Furthermore, companies who have
an established set of processes are in a great proactive position to quickly adapt to changing
regulations in comparison to those who will be forced to be reactive each time a regulation
changes.
INVESTING TODAY FOR
LONG-TERM VALUE
CASE STUDY: 1572’S
A large global Pharmaceutical Company,
was anticipating an audit by the FDA for
several of its time-sensitive submissions.
They did not have visibility in the end-to-
end process, were not able to track or report
on the status of these submissions and were
at risk of receiving a warning letter for non-
compliance. The company required an
assessment and optimization of the
processes and supporting procedural
documentation to ensure compliance with
regulated submission timelines and a
mechanism for tracking and reporting
against those timelines. Some of the
identified processes were cross-functional in
nature and spanned multiple systems;
alignment of functions and streamlining the
fragmented systems was a key measure for
successful delivery.
Within 6 months of implemen6ng
the op6mized processes the
companies compliance rate was
significantly improved; they were
able to confidently report metrics,
and saw a MEASURED
IMPROVEMENT FROM A
BASELINE OF 30% TO 96%
COMPLIANCE RATE for their
1572 submissions.
ONCE A COMPANY ESTABLISHES THEIR FRAMEWORK FOR COMPLIANCE
AND ARE ABLE TO REPORT METRICS ACCORDINGLY, THE RISK OF
WARNING LETTERS, COSTS OF INEFFICIENCIES AND LACK OF
TRANSPARENCY IN THE ORGANIZATION AND CAN BE PUT TO REST.

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Regulations are consistently changing, and that constant churn will not stop, it is simply the
nature of the global pharmaceutical landscape. Putting in place optimal processes today,
ensures your organization is ready for the next set of regulation changes that are on their way.
Companies who stall on change will find themselves in an unfavorable reactive situation, in
which they establish business practices that are a “band aid” approach, and tend to be loaded
with inefficiencies (intensive time constraints and cost and recourse overloads).
STAYING AHEAD OF THE REGULATIONS
AND YOUR COMPETITION
CASE STUDY: 2253’S
Companies who have an established
proactive approach to optimizing their
business processes have proactively
transitioned from paper submissions to
electronic submissions as early as
2011, today these companies are well
positioned to proactively address the
upcoming requirements of submitting
2253s via eCTD. Companies who are
still submitting their 2253’s in paper
will need to make a leap in preparation
for the e-CTD requirements.
ESTABLISHING A ROBUST PROCESS AND THEN PROACTIVELY MODIFYING
THE PROCESS AS REGULATIONS CHANGE AND AS NEW TECHNOLOGY
BECOMES AVAILABLE IS THE MOST SUCCESSFUL APPROACH TO
MAINTAINING PROCESS EXCELLENCE.
Companies who have a pro-active
process culture have started to
implement critical changes to their
Data and Information structures in
readiness for IDMP.
CASE STUDY: IDMP

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For more information, please contact:
Dalia El-Sherif, PhD
Partner
Pyxa Consulting Practice Lead
delsherif@pyxasolutions.com
610-909-8831
Mike Swalina
Partner
Pyxa Operations Practice Lead
mswalina@pyxasolutions.com
610-427-9570
Pyxa Solu.ons is
comprised of a
dynamic team of
management
consultants and
R&D subject ma@er
experts specializing
in cross-func.onal
R&D delivery
stemming from
ac.vi.es led by
Regulatory Affairs
Delivering over 100+
engagements In
over 40 companies,
Pyxa offers robust
professional services
in strategic and
opera.onal business
and technology
solu.ons for the
Pharmaceu.cal,
Biotech and Medical
Device industries
Our opera.onal,
strategic, consul.ng
and technology
services span across
R&D with a focus on
all regulatory
special.es within and
across the en.re
product lifecycle, for
both major and
emerging markets
ABOUT PYXA