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Synchrogenix Information Strategies Inc.
What Synchrogenix Offers Largest regulatory and medical writing company 23 years of experience  Expertise in supporting global pharmaceutical and biotech companies  Significant small and large molecule experience Scalable solutions Writers who are all permanent employees  (no contractors)  Complete outsourcing capability
Synchrogenix focuses on the writing component  to support drug approval and commercialization.  We collaborate with our clients to develop the key messaging  for each document type. Medical Writing Regulatory Submissions MD Education Marketing Publications
Synchrogenix Locations North American Locations: Wilmington, Del. Malvern, Penn. Boston, Mass. European Location: High Wycombe, Buckinghamshire Asia Pacific Location: Manila, Philippines
Synchrogenix Methodology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Synchrogenix Talent  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Security & Confidentiality ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Drug Approval—Regulatory Writing Spanning the product lifecycle for standardized regulatory submissions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Years 1 16 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Early Phase Activity  IND CTA Filing  NDA/MAA  Licence Application Drug Discovery  Drug Development  Target and Lead Identification Lead Optimization Concept Testing  Development for Launch  Launch Clinical Development Phase  I 50-150 people  Phase  II 100-200 people Phase  III 500-5,000 people Phase  IV  Studies Continue Product Life Cycle Support Preclinical and Clinical Writing Drug Safety & Pharmacovigilance CMC:  Chemistry, Manufacturing, & Controls Regulatory Operations & Project Management The Path to New Medicine Clinical  Phase I-III  Post Marketing  Activities Whether we work with your internal resources or your third parties,  Synchrogenix can step in or out at any time or stage.
Preclinical & Clinical ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Define Pharmacology & Toxicology Confirmation of Safety Profile  Confirmation of Efficacy in Target Populations Pooled Data Analysis Monitor & Evaluate
Drug Safety & Pharmacovigilance ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Build Safety Risk Awareness Identify Safety Risk Issues  & Develop Options Monitor & Evaluate
CMC:  Chemistry, Manufacturing, & Controls ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Formulation & Process Development Tech  Transfer  Validation Data Integration Monitor
Regulatory Operations & Project Management ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Template & Process Design Document Management Publish Maintain
Synchrogenix Delivers World-Class Performance in Medical Writing Synchrogenix Traditional  CRO  Players Traditional BPO Players Scope of expertise Depth of expertise in medical writing High Medium Low Knowledge of global regulations and guidances High Medium/High Low Therapeutic expertise High High Low Document services and management High Medium Medium Data interpretation High High Medium Quality Quality control and assurance High Medium Medium/Low Communication High Medium/High Medium Cost Cost savings Medium/High Low High Operational Process integrity High Medium High
Why Synchrogenix? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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Synchrogenix Inc Capabilities Presentation Jan 2010 Final

  • 2. What Synchrogenix Offers Largest regulatory and medical writing company 23 years of experience Expertise in supporting global pharmaceutical and biotech companies Significant small and large molecule experience Scalable solutions Writers who are all permanent employees (no contractors) Complete outsourcing capability
  • 3. Synchrogenix focuses on the writing component to support drug approval and commercialization. We collaborate with our clients to develop the key messaging for each document type. Medical Writing Regulatory Submissions MD Education Marketing Publications
  • 4. Synchrogenix Locations North American Locations: Wilmington, Del. Malvern, Penn. Boston, Mass. European Location: High Wycombe, Buckinghamshire Asia Pacific Location: Manila, Philippines
  • 5.
  • 6.
  • 7.
  • 8.
  • 9. Years 1 16 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Early Phase Activity IND CTA Filing NDA/MAA Licence Application Drug Discovery Drug Development Target and Lead Identification Lead Optimization Concept Testing Development for Launch Launch Clinical Development Phase I 50-150 people Phase II 100-200 people Phase III 500-5,000 people Phase IV Studies Continue Product Life Cycle Support Preclinical and Clinical Writing Drug Safety & Pharmacovigilance CMC: Chemistry, Manufacturing, & Controls Regulatory Operations & Project Management The Path to New Medicine Clinical Phase I-III Post Marketing Activities Whether we work with your internal resources or your third parties, Synchrogenix can step in or out at any time or stage.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14. Synchrogenix Delivers World-Class Performance in Medical Writing Synchrogenix Traditional CRO Players Traditional BPO Players Scope of expertise Depth of expertise in medical writing High Medium Low Knowledge of global regulations and guidances High Medium/High Low Therapeutic expertise High High Low Document services and management High Medium Medium Data interpretation High High Medium Quality Quality control and assurance High Medium Medium/Low Communication High Medium/High Medium Cost Cost savings Medium/High Low High Operational Process integrity High Medium High
  • 15.