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Drug Delivery Practice
                            Methodology
                          Project Execution
                           Client Delivery




Identifying opportunities, providing insightful advice, hands on execution



                                                                             1
In LifeScience!



• Founded in 2008.
• Worldwide customer base in pharmaceuticals, homecare and medical
  devices.
• In depth range of comprehensive services to LifeScience clients – from
  strategy and business development, acquisition know-how, marketing
  through operations, engineering, R&D and out-sourcing.




            Identifying opportunities, providing insightful advice, hands on execution   2
Our methodology

                   Timely delivery
                   Validation
                                              Result
                   Beyond expectations
                   Customer satisfaction

                                                                           Project management
   Functional analysis
                                                                           Hands on execution
   Risk analysis
                                           On Time to                      Resource availability
   Measurement                              Market
                                                                           Timely action plan
   Expertise assessment

               Analysis                                               Management



           Identifying opportunities, providing insightful advice, hands on execution              3
We Resolve Complex Projects


                    DRUG                                           DELIVERY
                  COMPOUND                 BCPharMed                DEVICE
                                             DRIVER


                                                                           Syringe
                                      Project management
                                       Compatibility value
                                        Product mapping                    Pen injector
     New formulation
                                         Process mapping
                                       Regulatory strategy
                                  Suppliers selection/validation           Patch
     Biotech start-up
                                     Engineering action plan
                                       Operations strategy
                                       Production planning                 Membrane
     New delivery method
                                      Quality measurement
                                         Project delivery
                                                                           Other DDS




            Identifying opportunities, providing insightful advice, hands on execution    4
We Resolve Complex Projects



                PROCESS                                         PRODUCT
                                        BCPharMed
                                          DRIVER


                                                                        Syringe
      Assembly
      Compounding                  Project management
      Conveying                     Functional analysis                 Pen injector
      Sterilization                    Product FMEA
      Isolation                       Process mapping
      Technology                    Regulatory strategy                 Patch
      Cleaning/washing         Suppliers selection/validation
      Filling                     Engineering action plan
      Tableting                     Operations strategy                 Membrane
      Inspection                    Production planning
      Labeling                     Quality measurement
      Packaging                       Project delivery                  Other DDS




          Identifying opportunities, providing insightful advice, hands on execution   5
Our Expertise

• Due dilligence.
• Marketing strategy
    –   Marketing surveys
    –   Marketing strategy
• Industrial strategy.
    –   Road map for industrial scale-up
    –   Project engineering management
    –   Production site management
    –   SupplyChain organization and plan
• Outsourcing
    – Turnkey project
    – Supplier selection




               Identifying opportunities, providing insightful advice, hands on execution   6
Our Expertise

•   Therapeutics product development.
•   Chemical and biochemical analysis.
•   Controlled environment, isolation technologies.
•   Sterilization methods, concepts, development & validation.
•   cGMP and ISO compliance.
•   Molding, assembly, filling, packaging under clean or sterile areas.
•   Process optimization and measurement.
•   Particulate and molecular contamination control.
•   Pharma and biopharma process and building engineering.
•   Pilot and production services.




             Identifying opportunities, providing insightful advice, hands on execution   7
Our Competitive Advantage

       Key Resources

        Focused LifeSciences Group
         Established Worldwide Client Base
          Unique Project Process
           Sector Leadership
             5 Years Track Record
                                                                                 Adding Value

                                                                                 Business Intelligence
                             What Makes Us Different                               Top Team Advice
 BCPharMed                    Our People                                             Due Diligence
                               Global Resources
  Distinctive                                                                          Market Research
                                Pharma and Medical Device Best Practice
                               General and Functional Management
                                                                                     R&D Cycle Times
 Competence                                                                         Outsourcing
                              Advisory and Hands On Execution
                             Totally Outcomes Focused                             Product / Process Transfer
              © 2008-2013 Sibaya BCPharMed                                       Manufacturing Performance
             Our Capability                                                    Quality Improvement
            Worldwide Reach
                                                                              International Sales
           Board & General Management Advisory
        Operations Management Excellence
      Research & Development Facilitators
     Business Development Projects
   Sales & Marketing Execution
  Acquisition Enablers
                               Identifying opportunities, providing insightful advice, hands on execution      8
For more information




                                 Contact
                            Bruno Cocheteux
                       bcocheteux@bcpharmed.com
                             +33 4 76918573




      Identifying opportunities, providing insightful advice, hands on execution   9

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Bcpharmed presentation february_10_2013

  • 1. Drug Delivery Practice Methodology Project Execution Client Delivery Identifying opportunities, providing insightful advice, hands on execution 1
  • 2. In LifeScience! • Founded in 2008. • Worldwide customer base in pharmaceuticals, homecare and medical devices. • In depth range of comprehensive services to LifeScience clients – from strategy and business development, acquisition know-how, marketing through operations, engineering, R&D and out-sourcing. Identifying opportunities, providing insightful advice, hands on execution 2
  • 3. Our methodology Timely delivery Validation Result Beyond expectations Customer satisfaction Project management Functional analysis Hands on execution Risk analysis On Time to Resource availability Measurement Market Timely action plan Expertise assessment Analysis Management Identifying opportunities, providing insightful advice, hands on execution 3
  • 4. We Resolve Complex Projects DRUG DELIVERY COMPOUND BCPharMed DEVICE DRIVER Syringe Project management Compatibility value Product mapping Pen injector New formulation Process mapping Regulatory strategy Suppliers selection/validation Patch Biotech start-up Engineering action plan Operations strategy Production planning Membrane New delivery method Quality measurement Project delivery Other DDS Identifying opportunities, providing insightful advice, hands on execution 4
  • 5. We Resolve Complex Projects PROCESS PRODUCT BCPharMed DRIVER Syringe Assembly Compounding Project management Conveying Functional analysis Pen injector Sterilization Product FMEA Isolation Process mapping Technology Regulatory strategy Patch Cleaning/washing Suppliers selection/validation Filling Engineering action plan Tableting Operations strategy Membrane Inspection Production planning Labeling Quality measurement Packaging Project delivery Other DDS Identifying opportunities, providing insightful advice, hands on execution 5
  • 6. Our Expertise • Due dilligence. • Marketing strategy – Marketing surveys – Marketing strategy • Industrial strategy. – Road map for industrial scale-up – Project engineering management – Production site management – SupplyChain organization and plan • Outsourcing – Turnkey project – Supplier selection Identifying opportunities, providing insightful advice, hands on execution 6
  • 7. Our Expertise • Therapeutics product development. • Chemical and biochemical analysis. • Controlled environment, isolation technologies. • Sterilization methods, concepts, development & validation. • cGMP and ISO compliance. • Molding, assembly, filling, packaging under clean or sterile areas. • Process optimization and measurement. • Particulate and molecular contamination control. • Pharma and biopharma process and building engineering. • Pilot and production services. Identifying opportunities, providing insightful advice, hands on execution 7
  • 8. Our Competitive Advantage Key Resources Focused LifeSciences Group Established Worldwide Client Base Unique Project Process Sector Leadership 5 Years Track Record Adding Value Business Intelligence What Makes Us Different Top Team Advice BCPharMed Our People Due Diligence Global Resources Distinctive Market Research Pharma and Medical Device Best Practice General and Functional Management R&D Cycle Times Competence Outsourcing Advisory and Hands On Execution Totally Outcomes Focused Product / Process Transfer © 2008-2013 Sibaya BCPharMed Manufacturing Performance Our Capability Quality Improvement Worldwide Reach International Sales Board & General Management Advisory Operations Management Excellence Research & Development Facilitators Business Development Projects Sales & Marketing Execution Acquisition Enablers Identifying opportunities, providing insightful advice, hands on execution 8
  • 9. For more information Contact Bruno Cocheteux bcocheteux@bcpharmed.com +33 4 76918573 Identifying opportunities, providing insightful advice, hands on execution 9