1. Pharmaceutical Analytical and Stability
Study
Outsourcing To Stabicon
Presented
By
Vijay Kumar Ranka
Stabicon Life Sciences Pvt. Ltd.
www.stabicon.com
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2. Index
Part:
1. Introduction
2. Changing Industry Trend of Pharma
3. Criteria for Selecting Offshore Outsourcing Unit
4. Outsourcing Process
5. Outsourcing Requirement
6. Risk and Mitigation
7. Benefit of Outsourcing
www.stabicon.com
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3. Part - 1
Introduction

4. Changing Industry Trend of Pharma
Present Pharma Industry Challenges
• Revenue under pressure
• Cost and risk of developing new drugs are increasing
• Globalization
How to Over Come the Present Challenges
• Corporate restructuring
i) Consolidation within industry, refocusing on fewer business lines
ii) Adoption of risk reduction strategies
iii) Acquisition rather than development, Use of Joint ventures
www.stabicon.com
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5. Outsourcing Redefined
Outsourcing is “strategic management tool” that involves the restructuring of
an organization around its core competencies
• Outsourcing is thus a transfer or delegation of an organization's project /facility
management functions to an external firm.
•
Types of Outsourcing
• Onshore
• Offshore / Offsite
Onshore: Onshore outsourcing (also called domestic outsourcing) is the obtaining of
services from someone outside a company but within the same country.
Offshore: Offshore outsourcing involves sending certain types of work overseas to
be completed by independent third parties.
Offsite : Referring to a location other than the subject site
www.stabicon.com
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6. Offshore Pharma Countries
www.stabicon.com
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7. Why India??
•40%-60%
cost reduction
for off shored
process
t
India’s
Value
Proposition
ity
tiv
c
du
Pro
Quality
•Technical
manpower
resource cost
likely to
continue next
20-30years
Co
s
• Faster
turnaround
time
•Adoptability
to Different
Time zone
24X7 service
•Access to highly qualified – skilled pool
•Faster adoptability to New Technologies
www.stabicon.com
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8. Strength At A Glance
HR Management
• Enough human resource
• Quite easier to motivate and retain people
Infrastructure
• Better Infrastructure facilities at very low cost
• Best Net Connectivity & Resource Availability
• English Language Proficiency
• Expertise in New Technologies
• Quality Assured (A grade) & regulatory requirement
• Unexpected Cost Advantage
• Research & development Abilities & Skilled Manpower
• Excitement about Pharmaceutical in the area
www.stabicon.com
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9. Part - 2
Criteria for Selecting Offshore
Outsourcing Unit
www.stabicon.com
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10. How to Select ?
www.stabicon.com
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11. Outsourcing at Stabicon
www.stabicon.com
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12. Why Stabicon ?
•
•
Ability to work in joint ventures and across divisions, cultures and
countries
Ability to integrate an understanding of IP,Scientific expertise and
business strategy
Ability to spur creativity while managing commercially
Expertise in functioning and decision making of regulatory
requirement
Human resource skills to transform Pharma companies
•
Dedicated support systems for web interface with real time information
•
Quality system must meet regulation in multiple markets plus clients
internal standards
•
•
•
www.stabicon.com
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13. Stabicon: Quality Not Quantity
• Quality is the new buzzword and is dominating business process and services
like never before in this sector.
•
Quality is no longer an oral guarantee given over handshake, but Stabicon has
well defined set of criteria are applied to the entire process.
•
Stabicon Standards of quality are par with, if not superior to your counterparts
requirement aboard.
www.stabicon.com
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14. What Can be Outsourced?
As per International Regulatory Requirements like
ICH, WHO, USFDA, MHRA, EMEA, MCH, TGA, ANVISA, ETC…
•
Stability Study Programs
•
Customized Stability Study program to meet specific dosage requirements.
•
Analytical Method Development & Validations.
•
Bio-waiver Studies (Comparative Dissolution Profiles) and Formulation
Development
•
Impurity Profiling / Stability Indicating Methods
•
Microbiological Method Development & Validations
www.stabicon.com
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15. Stabicon Capabilities
• Major installations are 21CFR Part 11 compliance.
• Assured Data Integrity through online web-access monitoring and willing to share
entire manuscripts & Raw-data.
• Assured Data Security through Central Networking Software for entire
chromatographic data management.
• 24x7 Data online monitoring for assured Stability Programs.
• Validated LIMS for Efficient Stability Program & Sample Management.
• Dedicated & Independent Quality Assurance Unit.
• Accreditation : Approved by Health Canada as per Compliance to Division 2 of
F&DR(GMP)
• In the process of accreditation from WHO GPQCL & ISO 17025 : 2005
www.stabicon.com
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16. Flexibility
• Flexibility of being able to access a large pool of resources working on various
Project and increasing / decreasing the teams at a short notice.
• Flexibility to select the team jointly from the best
handpicked from Indian Pharma Industry
pharmaceuticals brains
• Higher availability of our team to manage contingencies as they work 6 days a
week and available at odd hours even on Sundays for emergencies. The team
can also work at normal office timings of your country.
• Team are trained to understand the culture of your country, thereby leading to
better communication and co-ordination across the teams.
• Based on varied experience, the processes are designed to comply with the
industry's best practices and standards, enabling total transparency, access &
control of our team .
• Flexible engagement contract, leading to managed business risks.
www.stabicon.com
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17. Information Management System
User name with
safe password
World Wide
Client
Location
Internet
usage/Web based
Application
/Empower/LIMS
and etc.
Stabicon
Email Usage
Phone Lines
Regular phone
no. in World
wide
Skype
Usage/VC Line
www.stabicon.com
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18. Stabicon Advantage
• Modest sized company with extensive experience of offering offshore services to
clients globally.
Advantages:
• Competitive pricing & risk sharing (dedicated model, incentive model, royalty
model) Speed & agility (response time)
• Drastic reduction of your operating costs.
• Gain access to the world-class pharmaceutical skills.
• Seek resources not available in-house.
• Finish projects which otherwise cannot be finished in-house due to technical or
staff limitations.
• Free up non-capital resources for other in-houses projects.
• Gain a fresh and new perspective on a stalled project.
www.stabicon.com
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19. Part - 3
Outsourcing Process
www.stabicon.com
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20. Outsourcing Process
PILOT PROJECT
CLIENT SATISFACTION
AGREEMENTS
NECESSARY TRAINING
ACTUAL OUTSOURCING
IMPLEMENTATION
QUALITY CHECKS
FINAL OUTPUTS
www.stabicon.com
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21. Best Practices in Outsourcing Processes
Outsourcing to Stabicon should be much more than off shoring
Outsourcing to Stabicon should be much more than off shoring
and staff augmentation
and staff augmentation
Adopt a partnership based approach to Stabicon outsourcing
and move towards a competency based vendor selection
Best
Practices
Follow a staged approach for transition to an offshore partner
with a careful selection of projects
Prepare detailed transition plans for each project, especially
Stability projects
Establish strong governance and management oversight to
manage relationship and performance
Ensure that outsourcing processes are tailored to your business
requirements
www.stabicon.com
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22. Project Transition Plan – Details For Individual
Project
Project Stage Project Planning
Knowledge
Acquisition
Duration
1 – 2 Weeks
Description
2 – 4 Weeks
 Establish Project
scope, Expectations Member of
and Criteria for
Stabicon team
work with client to
Success
understand
 Set team
Document
composition,
System/ Process
requirements
 Finalize
and performance
metrics
transition plan
Stabicon/Offshore Transition
Stabicon Simulation
3 – 4 Weeks
 Execution
of project as
per approved
protocols
Review and
approval of
reports by
client
Stabicon Training/Pilot
2 – 3 Weeks
Establishment
of coordination
team, process
and metrics
Program for
Stabicon
Stabicon
Execution
Ongoing
Complete
fulfillment of
projects request
by Stabicon as
agreed upon
Service Levels
Agreements
Client Staff FTE
Off – shore
Stabicon Staff FTE
www.stabicon.com
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23. A Staged Approach Helps Transition to Offshore
Partner
Complete
outsourcing
Increase
scope and
scale
Test
Typical
projects

Short projects

Method
validation &
Stability
testing

Complete
MD,MV &
Stability
program
Key Success Factors in
a Transition
 Involve the end user
closely in the transition
• Discuss in existing
governance forum
• Involve end user in
oversight
Increasing management complexity and mission criticality
www.stabicon.com
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24. Critical Practices For – Strong Governance &
Management
Best Practices
Key Levers
•
Partnership
Board
•
•
Relationship
Management
Performance
Management
•
•
•
•
•
•
Partnership board consist of both senior management from both sides is
the final decision making authority
Every quarter, partnership board should consist of senior review the level
of outsourcing and the performance.
Every year, partnership board conducts joint strategic technology planning
sessions
Day-to-day project management would be performed by dedicated
relationship managers from each side
Relationship managers will facilitate smooth project execution, define
processes and act as trouble shooters
Performance tracking should be automated and Commitment tracker
Clear definitions of success and failure
Predefined processes for increased and decreased collaboration
Exit clauses that define responsibility and timelines for knowledge transfer,
documentation and intellectual property rights
www.stabicon.com
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25. Outsourcing to Vendors is more than Offshoring
and Staff Augmentation
“Winning” Mindset
“Traditional” Mindset
Use Stabicon for project components
Outsource complete projects
Maximize offshore component
Use offshore, offsite and onsite
presence judiciously
Use staff augmentation approach for
onsite presence
vs.
Maintain onsite presence for managing
and delivering solutions
Extend organization virtually (includes
development, management,
infrastructure projects, etc.)
Focus on development outsourcing
only
www.stabicon.com
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26. Advantages of Partnership
“Partnership” approach
“Transaction” approach
No long term commitment
Medium/Long term commitment
RFP issued for every project
Competency based vendor selection
Stabicon not expected to invest
Stabicon expected to invest in
infrastructure, knowledge transfer,
etc.
vs.
Stabicon expected to leverage their
knowledge base and contribute to
overall strategy and planning issues
Stabicon follow customer orders with
limited value added
Vendors not involved in technology
strategy and planning
Stabicon expected to be actively
involved in technology planning
Insufficient focus on risk mitigation
Proactive measures for mitigating
risks
www.stabicon.com
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27. Technology Provider Successfully
Follow a Phased Approach for Partnership
Year : 2015
No. of people : 10-15
Marked up
SLAs
Scaled
down SLAs
to give time
to Stabicon
Year : mid 2013
No. of people : 3-5
Year : 2012
No. of people : 1-2
• Development
project to test
Stabicon capability
• low priority and low
complexity project
of a small
component
• Medium priority
and medium
complexity
Year : 2014
No. of people : 7-10
Year : 2013
No. of people : 5-7
• Medium priority
and medium
complexity
project
(including
analysis and
reporting)
• High priority and
high complexity
• Full testing of
products
• Contribution to
new releases
(development)
Partnership /
Joint Venture
Client onsite
governance
SLA  Service Level Agreements
Moving up the value chain with increasing customer confidence in Stabicon capabilities
www.stabicon.com
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28. Partnership Ladder
Y Axis
X Axis
www.stabicon.com
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29. Partnership Model Has Benefits
• Enables Stabicon to offer lower
pricing because they have better
visibility into revenue streams
• Reduces the Stabicon total cost of
doing business which can be passed
to customer.
• Learning curve benefits
help in improving quality
• Allows Stabicon to
prepare resource plan in
advance and staff
projects with appropriate
resources
• Helps achieve best
practice transfer by
Stabicon
Cost
• Learning curve
benefits help in
faster time to market
• Releases important
customer resources
for more value added
work
• Reduces time spent
in the RFP process
Time to market
Quality
www.stabicon.com
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30. Business Models
Time & Material Model
Build-Operate Transfer Model
Build an offshore facility for the
customer, Operate the offshore
facility & customize it as per
customer's needs & when model
reaches maturity, Transfer the
complete ownership of the facility
& resources to the Client.
Fixed Price Model
Hybrid Model
A major portion of project is on a
Fixed Price basis and at the
same time resources are
deployed on Time and Material
basis. Adopting such a model
enables the client to maximize
their ROI without compromising
any aspect of the project itself.
Define the business model and
work hand in hand with our client.
The client pays a fixed FTE rate.
Dedicated Development
Centre Model
Extension of the customer's
software engineering facility.
The customer pays fixed
monthly rate for the Team.
The customer pays a Prenegotiated Fixed price for the
complete project, which in turn
is linked to well-defined
deliverables.
www.stabicon.com
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31. Part 4
Outsourcing Requirement
www.stabicon.com
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32. Metrics Required to Support Outsourcing
• Form a cross-functional team
• Determine communication plan
• Determine and finalize work plan
• Define measurable deliverables.
• Finalize data review and approval process
• Finalize process to review out of specifications/OOT results
• Have periodic meetings to review work
www.stabicon.com
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33. Structure Required at Client Site to
Support Outsourcing
 Project Coordinator Overall co-ordination of the project.
 Logistics
Handling of Sample shipment
 Quality Control
transfers
Co-ordination of specifications ,method
stability protocols and stability results.
 Quality Assurance
Approval of Out of specifications
www.stabicon.com
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34. Part 5
Risk and Mitigation
www.stabicon.com
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35. Outsourcing Confusion
Outsourcing – In many organization
around outsourcing can cause
emotional equivalence of a political
or religious debate due to confusion
www.stabicon.com
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36. Outsourcing Risk
www.stabicon.com
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37. Risks Associated with Outsourcing to
Stabicon Manageable
Perceived risks
Talent
Project
Why we believe risks
can be managed
High attrition rates due
to large demand
Stabicon is investing heavily in
training.
Complex projects have
many failure points
3level review on project at
Stabicon
Active governance policies with
interactions at all levels
Differences in work
culture
Cultural
Electricity and telecom
not reliable
Different IPR laws
Infrastructure
Geopolitical events can
destabilize trade e.g.
with India
Political/Country
www.stabicon.com
Vs.
Leading team at Stabicon have
been proactively trained to
handle culture gaps
Government actively promoting
uninterrupted power supply and
telecom to technology
companies
Established legal system
US and Indian Governments
agreed to de-link the
pharmaceutical trade from
politics
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38. Cultural Gaps
Risk:
 Corporate culture clash to the difficulties in managing an outsource
provider across large distances and different time zones
 Throw in regulatory concerns and proprietary information and
relationship management becomes even more difficult.
Mitigation:
 Focus on the performance and cost, but don’t let the service provider
lead down path of vendor lock-in.
 Avoid exclusivity in the contract.
www.stabicon.com
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39. Customer Relationship Management
Risk:
 Managing expectations and maintaining relationship with service
providers is essential for the success.
 Offshore contract do meet expectations because
I) Firms outsourcing without a clear methodology
ii) Disconnect between expectations at management level and what’s
actually delivered at the processes level.
Mitigation:
 By making sure the parties share a common understanding regarding
critical interactions at the Operational & Management Level for
successful outsourcing
www.stabicon.com
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40. Knowledge Transfer
Risk:
 Transfer of knowledge from both side of a contract is critical otherwise
can lead to broken connectivity .
Mitigation:
 Services require external & internal support
 This result in Decline of productivity during first year of an agreement,
largely due to time spent transferring
www.stabicon.com
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41. Implied Cost savings
Risk
• Estimate most firm save 30-35% during first year; by third year, cost
savings often reaches 40-45% as companies “go up learning curve “
for outsourcing and modify operations to align to an offshore model.
• Outsourcing solely control cost can lead alignment issue and
increased project delay.
Mitigation
• Corporation should provide strategy to its business lines of business to
allow them to outsource within guidelines.
• Brings in the strategic differential advantage of offshore outsourcing to your
business, thereby, enhancing your profitability
• Once firm understand its outsourcing drivers, selecting which
application to outsource becomes straight forward.
www.stabicon.com
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42. Compliances
Risk:
 Product failure/Regulatory/Security compliance failure is in fact one of
the top concerns companies face when outsourcing services to
external vendor.
Mitigation:
 The key to successful and secure outsourcing agreement is
understanding
i) Regulatory compliance followed by schedule third party Audits
ii) Security covered by Legal Agreement
iii) Privacy risks for a business process covered by CDA
iv) Application or technology function outcome covered by Technical
Agreement
www.stabicon.com
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43. Sample Shipment Procedure
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Mitigation:
•
Samples need to be shipped by Air freight cargo mode
•
For temperature sensitive products special containers can be used and
temperature can be monitored
•
Pro forma Invoice detailing product name , quantity and value
•
Declaration for customs purposes stating the value of the product
•
Documents can be faxed to Stabicon for rechecking
•
Sample shipment after clearance from Stabicon
•
Samples will be cleared by Stabicon from Indian customs
•
Timelines for customs clearance : 3 to 5 working day
www.stabicon.com
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44. Minimizing Risk
• Choose a service provider who provides you with value adds, services or
products that may not be in the contract.
• Develop a strong partnership with the vendor
• Simplify the interface between the two organizations
•
• Choose a service provider that has a proven track record - talk to customers of
the service provider
• Know your requirements, both current and future, and put them in the contract
• Stay away from variable costs in the contract like communication, travel etc.
• Treat the outsourced relationship as a partnership and the employees and
extended team members
www.stabicon.com
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45. Part 7
Benefit of Outsourcing
www.stabicon.com
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46. Your Benefit as a Customer
Reduced
Operating Cost
Increased
Productivity
Increased
Profits
Custome
r
Quick Turn
around Time
Better
Quality
www.stabicon.com
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47. Client High Growth Area can be Focused
• Commercialization of Dormant Compounds
• Generic or Biosimliar Versions of biologics
• Improving the efficiency of R&D
• Oncology and central nervous system disorder research
• Stratified Medicine and diagonistic
• Fusion of Pharmaceutical and consumer goods
www.stabicon.com
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48. Thanks
For any query,
Please contact us at
Stabicon Life Sciences Pvt. Ltd
3BM – 416, 3rd Block,
HRBR Extension,
Bangalore – 560 043 INDIA
Phone: +91 80 4171 4280 / 81
e-mail : info@stabicon.com
www.stabicon.com
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