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Synterex, Inc.
The agile clinical & regulatory consulti...Products
Medical Affairs *
Scientific Communications Development
Strategic Stakeholder Engagement
Defining the Value of Medical Affairs
Evidence Generation
Strategic Communications Planning
Regulatory *
Labeling & Promotions
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Transparency & Disclosure
Commercialization *
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Finance & Investment *
Financial Services
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Facilities & Equipment
Testing & Release
Quality Management
Production & Supply Chain
Clinical Research *
Real World Data Research
Study Operations & Management
Clinical Reporting
Product Development
Trial Design & Planning
Technology & Operations *
Automation & Efficiency
Data & Analytics
Early Development
Digital Health Solutions
Operations
Informatics Infrastructure
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Projects
Medical Affairs *
Scientific Communications Development
Strategic Stakeholder Engagement
Defining the Value of Medical Affairs
Evidence Generation
Strategic Communications Planning
Regulatory *
Labeling & Promotions
Maintenance & Renewals
Compliance
Transparency & Disclosure
Commercialization *
Customer Engagement
Brand Planning & Activation
Market Access & Policy *
Government Policy
Global Market Access
Pharmacovigilance *
Safety Systems
Risk Management
Finance & Investment *
Financial Services
Investment Banking
Quality & Mfg *
Facilities & Equipment
Testing & Release
Quality Management
Production & Supply Chain
Clinical Research *
Real World Data Research
Study Operations & Management
Clinical Reporting
Product Development
Trial Design & Planning
Technology & Operations *
Automation & Efficiency
Data & Analytics
Early Development
Digital Health Solutions
Operations
Informatics Infrastructure
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About
2016
122 Rosemary Road, Dedham, MA 02026 7027, USA
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E P
an Associate General Management
(White Paper) This One’s for the Children: Progress in Pediatric Drug Development in the United States
Prior to the FD&C Act, pharmaceutical companies were not required to provide proof of drug safety or a disclosure of all active ingredients. Since then, all new drugs undergo an intensive review process by the Food and Drug Administration (FDA), and ever-evolving guidance and regulations ensure that both new drugs and those with updated characteristics, such as dosing, delivery, and expanded indications, are safe and effective for the intended populations. A gap remains, however, for drug investigations including and targeted for children of varying ages.
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E P
an Associate General Management
(White Paper) The Road to Representation in Clinical Research
Innovative development of human drugs, biologics, and medical devices (medical products) and their quick advancement through the United States Food and Drug Administration (FDA) approval pipeline is necessary to improve the lives of patients. It is also imperative for sponsors to consider diversity when enrolling study participants throughout the clinical development pipeline to adequately represent the population of patients who have a disease or condition.
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