Stabicon 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 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.
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
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Accredited by ISO / IEC
17025:2005 (NABL)
Approved by Health Canada
Registered with DSIR
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Approved by FDA (India)
Registered with US FDA
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Regulatory Compliance
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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
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Consumer /OTC - Products
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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
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Experience & Diversity - Laboratory Business Segment
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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
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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
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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
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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