This One’s for the Children: Progress in Pediatric Drug Development in the United States
Posted by Elizabeth P.Synterex, Inc.
7 hours ago
Invite Supplier
Invite Supplier
Invite Supplier
Possible Duplicates
Available Companies
Select which of your Solution Providers you wish to view/edit.
Synterex, Inc.
The agile clinical and regulatory consulting firm.Synterex, Inc.
Products
Name
Category Selection:
Select any categories from those you have selected for your main listing. If you wish to include more categories, add them to your main listing first and after doing so, they will appear below.
Clinical Research *
5
Clinical Reporting
3
Abstract & Poster Development
Clinical Study Report Writing
Manuscript Development
Product Development
9
Analytical Methods Development
Clinical Research
Clinical Research Network Development
Clinical Trial Material Supply
Clinical Trials
Show More (4)
Document Management
Drug Product Manufacturing
Formulation Development
Submissions Management
Show Less (4)
Real World Data Research
6
Analytics Methods Development
Data Standardization & Curation
Evidence Prioritization
Late Phase Data Curation
Lifecycle Evidence Generation
Show More (1)
Observational Research
Show Less (1)
Study Operations & Management
6
Patient Recruitment
Site Contracting & Payments
Site Identification & Activation
Site Relationship Management
Study Tracking & Analytics
Show More (1)
Trial Implementation
Show Less (1)
Trial Design & Planning
6
Data Management Planning
Enrollment Analytics
Patient Recruitment Planning
Protocol Feasibility Planning
Software
Show More (1)
Statistical Analysis Planning
Show Less (1)
Commercialization *
2
Brand Planning & Activation
3
Brand Vision & Positioning
Campaign Concept Testing
Multi-Channel Campaign Launch
Customer Engagement
6
Omnichannel Optimization
Patient Engagement
Patient Facing Solution Design
Patient Journey Analysis
Retention Program Effectiveness
Show More (1)
Strategic Account Management
Show Less (1)
Finance & Investment *
2
Financial Services
4
Billing & Reporting Operations
Internal Audit Support
Investment Performance Analytics
Revenue Forecasting & Planning
Investment Banking
3
Buy & Sell Side Advisory
Capital Raising & Financing
Investor Relations
Market Access & Policy *
2
Global Market Access
5
Launch Sequencing
Payer Evidence Generation
Payer Relationship Management
Pricing Strategy
Reimbursement Consulting
Government Policy
2
Advocacy Management
Legislative Monitoring
Medical Affairs *
5
Defining the Value of Medical Affairs
1
Defining the Value of Medical Affairs
Evidence Generation
5
Clinical Trial Concepts
Health Economics Modeling
Internal Medical Education
Patient Journey Mapping
Research Gap Analysis
Scientific Communications Development
2
Market Access Advisory Panels
Payer Advisory Board Strategy
Strategic Communications Planning
3
Competitive Publications Analysis
Publication Planning
Scientific Platform Planning
Strategic Stakeholder Engagement
3
Advisory Board Strategy
KOL Relationship Management
Stakeholder Influence Mapping
Pharmacovigilance *
2
Risk Management
3
Risk Evaluation & Minimization
Risk Management Evaluation
Safety Communications
Safety Systems
3
Safety Data Analytics
Safety Data Intake & Triage
Safety Signal Evaluation
Quality & Mfg *
4
Facilities & Equipment
5
Calibration & PM Programs
Deviation Investigations
Equipment Maintenance
Facility Maintenance Programs
Facility Security Management
Production & Supply Chain
3
Clinical & Commercial Production
Labeling & Packaging
Storage & Distribution
Quality Management
3
Corrective Action Verification
Deviation Investigation
Quality Process Governance
Testing & Release
3
Batch Release Testing
Raw Material Testing
Stability Program Testing
Regulatory *
4
Compliance
5
Agency Meeting Support
Dossier & Application Development
eCTD Publishing & Validation
Pre-Submission Advisory Meetings
Regulatory Compliance
Labeling & Promotions
2
Core Data Sheet Management
Labeling Strategy Development
Maintenance & Renewals
3
Post-Approval Safety Reporting
Promotional Material Compliance
Variations & Supplements
Transparency & Disclosure
2
Clinical Disclosure
Clinical Transparency
Technology & Operations *
6
Automation & Efficiency
3
Clinical Data Automation
Lab Automation Systems
Supply Chain Automation
Data & Analytics
3
Advanced Analytics
Data Curation
Data Visualization
Digital Health Solutions
6
5G Infrastructure
Blockchain Applications
mHealth Applications
Patient Portals
Telemedicine Platforms
Show More (1)
Wearables & Sensors
Show Less (1)
Early Development
2
Clinical Supply Chain Automation
Clinical Trial Management Systems
Informatics Infrastructure
3
Cloud Computing Systems
Data Security Solutions
Data Storage Platforms
Operations
11
Communications
Communications & Corporate Affairs
Content Creation & Development
Human Resources & Talent Acquisition
Management Consulting
Show More (6)
Marketing
Medical Information Services
Medical Writing
Operations Management
Other
Public Relations
Show Less (6)
Product Site Link
Product Brochure Link
Email address for this product:
Phone Number:
Scheduler/Book Appointment URL: (e.g. https://calendly.com/)
Update primary listing to with the above contact information
Overview
0/200 chars
Description
Product Logo (200px X 200px)
Upload a square image that is approx. 200 x 200 px in size.
Crop Image
Projects
1
3
Project Name
Description
Project Logo (200px X 200px)
Upload a square image that is approx. 200 x 200 px in size.
3
3
Category Selection:
Select any categories from those you have selected for your main listing. If you wish to include more categories, add them to your main listing first and after doing so, they will appear below.
Clinical Research *
5
Clinical Reporting
3
Abstract & Poster Development
Clinical Study Report Writing
Manuscript Development
Product Development
9
Analytical Methods Development
Clinical Research
Clinical Research Network Development
Clinical Trial Material Supply
Clinical Trials
Show More (4)
Document Management
Drug Product Manufacturing
Formulation Development
Submissions Management
Show Less (4)
Real World Data Research
6
Analytics Methods Development
Data Standardization & Curation
Evidence Prioritization
Late Phase Data Curation
Lifecycle Evidence Generation
Show More (1)
Observational Research
Show Less (1)
Study Operations & Management
6
Patient Recruitment
Site Contracting & Payments
Site Identification & Activation
Site Relationship Management
Study Tracking & Analytics
Show More (1)
Trial Implementation
Show Less (1)
Trial Design & Planning
6
Data Management Planning
Enrollment Analytics
Patient Recruitment Planning
Protocol Feasibility Planning
Software
Show More (1)
Statistical Analysis Planning
Show Less (1)
Commercialization *
2
Brand Planning & Activation
3
Brand Vision & Positioning
Campaign Concept Testing
Multi-Channel Campaign Launch
Customer Engagement
6
Omnichannel Optimization
Patient Engagement
Patient Facing Solution Design
Patient Journey Analysis
Retention Program Effectiveness
Show More (1)
Strategic Account Management
Show Less (1)
Finance & Investment *
2
Financial Services
4
Billing & Reporting Operations
Internal Audit Support
Investment Performance Analytics
Revenue Forecasting & Planning
Investment Banking
3
Buy & Sell Side Advisory
Capital Raising & Financing
Investor Relations
Market Access & Policy *
2
Global Market Access
5
Launch Sequencing
Payer Evidence Generation
Payer Relationship Management
Pricing Strategy
Reimbursement Consulting
Government Policy
2
Advocacy Management
Legislative Monitoring
Medical Affairs *
5
Defining the Value of Medical Affairs
1
Defining the Value of Medical Affairs
Evidence Generation
5
Clinical Trial Concepts
Health Economics Modeling
Internal Medical Education
Patient Journey Mapping
Research Gap Analysis
Scientific Communications Development
2
Market Access Advisory Panels
Payer Advisory Board Strategy
Strategic Communications Planning
3
Competitive Publications Analysis
Publication Planning
Scientific Platform Planning
Strategic Stakeholder Engagement
3
Advisory Board Strategy
KOL Relationship Management
Stakeholder Influence Mapping
Pharmacovigilance *
2
Risk Management
3
Risk Evaluation & Minimization
Risk Management Evaluation
Safety Communications
Safety Systems
3
Safety Data Analytics
Safety Data Intake & Triage
Safety Signal Evaluation
Quality & Mfg *
4
Facilities & Equipment
5
Calibration & PM Programs
Deviation Investigations
Equipment Maintenance
Facility Maintenance Programs
Facility Security Management
Production & Supply Chain
3
Clinical & Commercial Production
Labeling & Packaging
Storage & Distribution
Quality Management
3
Corrective Action Verification
Deviation Investigation
Quality Process Governance
Testing & Release
3
Batch Release Testing
Raw Material Testing
Stability Program Testing
Regulatory *
4
Compliance
5
Agency Meeting Support
Dossier & Application Development
eCTD Publishing & Validation
Pre-Submission Advisory Meetings
Regulatory Compliance
Labeling & Promotions
2
Core Data Sheet Management
Labeling Strategy Development
Maintenance & Renewals
3
Post-Approval Safety Reporting
Promotional Material Compliance
Variations & Supplements
Transparency & Disclosure
2
Clinical Disclosure
Clinical Transparency
Technology & Operations *
6
Automation & Efficiency
3
Clinical Data Automation
Lab Automation Systems
Supply Chain Automation
Data & Analytics
3
Advanced Analytics
Data Curation
Data Visualization
Digital Health Solutions
6
5G Infrastructure
Blockchain Applications
mHealth Applications
Patient Portals
Telemedicine Platforms
Show More (1)
Wearables & Sensors
Show Less (1)
Early Development
2
Clinical Supply Chain Automation
Clinical Trial Management Systems
Informatics Infrastructure
3
Cloud Computing Systems
Data Security Solutions
Data Storage Platforms
Operations
11
Communications
Communications & Corporate Affairs
Content Creation & Development
Human Resources & Talent Acquisition
Management Consulting
Show More (6)
Marketing
Medical Information Services
Medical Writing
Operations Management
Other
Public Relations
Show Less (6)
2
3
Select multiple images
Crop Image
Add Image Caption
Crop Image
Add new card
Change Featured Content Owner
Crop Image
Crop Image
Back
Synterex, Inc.
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.
Show More
Get Your Copy
Edit Mode
Share via
