Contoso Ltd. is a GCLP compliant research center located in Bangalore, focused on stability and dosage development for pharmaceuticals, operating since 2010. The company is recognized for its advanced technology integration and quality management supported by a professional team of over 100 scientists, with numerous regulatory approvals including from WHO and the FDA. Their services encompass formulation development, regulatory compliance, stability programs, and microbiological testing, aimed at enhancing product quality in the prevention and cure pharmaceutical segment.

1. Stability & Dosage Development

2. Contoso Ltd.
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Stability
Center
2010
2012
2013
2014
2015
2016
2017
2018
2019
Health
Canada
Approval
WHO(Geneva),
ISO –
17025,Product
Certification
Center
Bio Wavier
Division
Formulation
Development
Center
Platform
Technology
Center
Metabolism
& Infection
(AMR)
Commercializat
ion of
Technology
Clinical Supply
History
Started Operation
Business Confidential

3. Contoso Ltd.
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• Located in Bangalore, a dedicated
cGLP Compliant research centre.
• Specialized in managing product quality process,
upgrading and introducing advanced technology into
products. we are proud to lay a foundation for prosperous
future in prevention and cure segment, future medicine &
FMCG business.
• Established in September 2010.
• Team experience spans across from design to concept, lab
to commercialization of product and with competent
technical experts.
• Automated Process driven and prepared for integration
with partner site for transparency and real time access on
each application.
Overview
Business Confidential

4. Contoso Ltd.
Audited and approved by WHO,
Geneva
01
Accredited by ISO / IEC
17025:2005 (NABL)
Approved by Health Canada
Registered with DSIR
2
1
3
4
5
6
02
03
04
05
06
Approved by FDA (India)
Registered with US FDA
4
Regulatory Compliance
Business Confidential

5. Contoso Ltd.
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• Professional Management with a strength of
100+ scientists.
• Strong management governance
• Lean Organization - quicker decision
• Integration functional area expertise under
one umbrella
• Easy to scale up or modify as most of process
are automated
• State of art infrastructure
• Compliant with EHS regulations
Infrastructure
Business Confidential

6. Contoso Ltd.
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Formulation & Development Bio waiver AMR - HTS
Microbial Studies
Platform Technology
Product & Device
Certification
Centralized Stability
Clinical Supply Referral lab & Turn KeyBrand
Services Suite
Business Confidential

7. Contoso Ltd.
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Consumer /OTC - Products
Business Confidential
 Change Management
 Technology Migration
 Quality Assessment and Review
 Troubleshooting/Defect
Analysis
 Pre – study
 Concept Design and Ideation
 Detailed Design and Analysis
 Final Design
 After Sales
 Performance Improvement
 Benchmarking
 Manufacturing Process Optimization
 Value Engineering
 Knowledge Based Engineering
 Design Automation
 Data and Model Recognition from Documents
Product Lifecycle
Product Sustenance
Growth Solution
Automation

8. Contoso Ltd.
Value Creation for
Centralized Information
Strengthen excellence &
process transformation
initiatives
Automation Initiatives
in the process
Development center for various
dosage Development
Stabicon Stability Program
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Stability Dedicated Center
Business Confidential

9. Contoso Ltd.
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Experience & Diversity - Laboratory Business Segment
Business Confidential
Experience & Diversity - Laboratory Business Segment
Method Development Method Validation/Verification Stability Program
Product Certification for WHO & India
Market Release
Spurious & Substandard product
Investigation
Experience 10 years 10 years 10 years 7 years 6 years
Dosage
Solid, Liquid, Topical,
Parenteral (Internal &
External Application)
Solid, Liquid, Topical, Parenteral
(Internal & External Application)
Solid, Liquid, Topical, Parenteral (Internal &
External Application)
Solid, Liquid, Topical, Parenteral (Internal
& External Application)
Solid, Liquid, Topical, Parenteral
Volume
( Annual)
100 - 200 300 - 500 500 - 700 1000 - 1200 250 - 400
Diversity
Pharmaceutical Rx & OTC,
Hygiene, Dietary,
Compounding, Biological,
Medical Device
Pharmaceutical Rx & OTC, Hygiene,
Dietary, Compounding, Biological,
Medical Device
Pharmaceutical Rx & OTC, Hygiene, Dietary,
Compounding, Biological, Medical Device
Pharmaceutical Rx & OTC, Hygiene,
Dietary, Compounding, Biological, Medical
Device
Dietary , Pharmaceutical Rx & OTC
Category
Chemical, Enzyme, Peptide,
Medical Device, Natural,
Probiotics based products
Chemical, Enzyme, Peptide, Medical
Device, Natural, Probiotics based
products
Chemical, Enzyme, Peptide, Medical Device,
Natural, Probiotics based products
Chemical, Enzyme, Peptide, Medical
Device, Natural, Probiotics based products
Chemical, Enzyme, Peptide based products
Market
America, Europe, Asia,
Australia, Africa, Canada,
Middle east
America, Europe, Asia, Australia,
Africa
America, Europe, Asia, Australia, Africa America, Europe, Asia, Australia, Africa Asia

10. Contoso Ltd.
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Critical Control For – Strong Governance & Management
Business Confidential
Governance
Board
• Governance 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
collaboration and the performance.
• Every year, partnership board conducts joint strategic technology planning sessions
Relationship
Management
• 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
Management
• Performance tracking will 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
Best PracticesKey Levers

11. Contoso Ltd.
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Project Transition Plan – Details for Projects
Knowledge
Acquisition
Project Planning Stabicon Simulation
Stabicon Training/Pilot
Stabicon
Execution
2 – 4 Weeks 1 – 2 Weeks 3 – 4 Weeks 2 – 3 Weeks Ongoing
 Establish Project
scope, Expectations and
Criteria for Success
 Set team composition,
requirements
and performance
metrics
Member of
Stabicon team work
with client to
understand
Document System/
Process
 Finalize transition
plan
 Execution of
project as per
approved
protocols
Review and
approval of
reports by
client
Establishment
of coordination
team, process
and metrics
Program for
Stabicon
Complete
fulfillment of
projects request
by Stabicon as
agreed upon
Service Levels
Agreements
Stabicon Transition
Duration
Description
Client Staff FTE
Off – shore
Stabicon Staff FTE
Project Stage
Business Confidential

12. Contoso Ltd.
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Process - Mapping
Business Confidential

13. Contoso Ltd.
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Method Development & Validation
 Verification of Accuracy & Adoptability of the Developed Method
 Development & Validation of Stability Indicating Methods
 Analytical Method Transfers
 Re-validations / Partial Validations As Per Customer Requirement
 As per requirements of ICH, USFDA, MHRA, MCC, WHO, ANVISA,
etc..
Method Development & Validations for
 Identification
 Purity
 Preservatives
 Anti-oxidants
 Colourants
 Assay
 Dissolution
 Uniformity of Content
 Related Substances
 Degradation Products
Business Confidential

14. Contoso Ltd.
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Stability Programs
ICH Compliant Storage
Chambers
5°C
25°C/ 60%RH
30°C/ 65%RH
30°C/ 75%RH
40°C/ 75%RH
Photo-stability
24/7
Data Monitoring,
Mobile Alert Systems
& Engineering
Team
Chambers & Software
Qualified as per
21 CFR part 11, ICH
&
GAMP-V
Guidelines
Current Capacity
1,00,000 Liters
Scalable to 100,000
liters
To accommodate
6000 to 25000
Batches
 Long-term Stability Studies
 Accelerated Studies
 Photo-stability Testing
 Zone IV Conditions
 Freeze Thaw Stability
 Customized Study
We undertake Stability Programs for
 R&D & Pilot Batches
 Process Optimization Batches
 Validation Batches
 Follow-up Batches
 Commercial Batches
 On-Going Batches
Business Confidential

15. Contoso Ltd.
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Microbiology
Validation of Microbiological Test
Bio-burden Test
Bacterial Endotoxins by LAL
Antibiotic Assay
Preservative Efficacy Testing
Efficacy Testing of AntibioticActivity
Efficacy of Chemical Disinfectants
Environmental Monitoring
Sterility
Business Confidential

16. Thank You
Business development Team
+91 80 41250324
bd@stabicon.com, info@stabicon.com
www.Stabicon.com