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
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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.
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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