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Home Suppliers FDA CDER Small Business and Industry Assistance (SBIA) Activity & Updates

FDA CDER Small Business and Industry Assistance (SBIA)

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Medical Affairs *

Scientific Communications Development

Medical Writing

Payer Advisory Board Strategy

Market Access Advisory Panels

Strategic Stakeholder Engagement

KOL Relationship Management

Advisory Board Strategy

Stakeholder Influence Mapping

Defining the Value of Medical Affairs

Evidence Generation

103

Clinical Trial Concepts

Internal Medical Education

Health Economics Modeling

Patient Journey Mapping

Research Gap Analysis

Strategic Communications Planning

Publication Planning

Medical and Scientific Communications

Scientific Platform Planning

Competitive Publications Analysis

Regulatory *

Labeling & Promotions

Labeling Strategy Development

Core Data Sheet Management

Maintenance & Renewals

Variations & Supplements

Post-Approval Safety Reporting

Promotional Material Compliance

Compliance

189

Regulatory Compliance

117

Dossier & Application Development

Pre-Submission Advisory Meetings

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Testing & Release

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Deviation Investigation

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Production & Supply Chain

Storage & Distribution

Labeling & Packaging

Clinical & Commercial Production

Clinical Research *

Real World Data Research

Data Standardization & Curation

Late Phase Data Curation

Analytics Methods Development

Lifecycle Evidence Generation

Real World Evidence

Show More (2)

Evidence Prioritization

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Study Operations & Management

133

Site Contracting & Payments

Study Tracking & Analytics

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Trial Implementation

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Clinical Reporting

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Product Development

264

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Clinical Research

158

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Clinical Trials

113

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Submissions Management

Formulation Development

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Trial Design & Planning

Protocol Feasibility Planning

Statistical Analysis Planning

Enrollment Analytics

Patient Recruitment Planning

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Lab Automation Systems

Clinical Data Automation

Supply Chain Automation

Data & Analytics

152

Data Curation

Artificial Intelligence

Data Visualization

Advanced Analytics

Early Development

Clinical Trial Management Systems

Clinical Supply Chain Automation

Digital Health Solutions

103

Managed Services

Global Connectivity

5G Infrastructure

mHealth Applications

Patient Portals

Show More (3)

Blockchain Applications

Telemedicine Platforms

Wearables & Sensors

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Medical Writing

Management Consulting

Other

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Show More (7)

Communications

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Product/Service

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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.

Medical Affairs *

Scientific Communications Development

Medical Writing

Payer Advisory Board Strategy

Market Access Advisory Panels

Strategic Stakeholder Engagement

KOL Relationship Management

Advisory Board Strategy

Stakeholder Influence Mapping

Defining the Value of Medical Affairs

Evidence Generation

103

Clinical Trial Concepts

Internal Medical Education

Health Economics Modeling

Patient Journey Mapping

Research Gap Analysis

Strategic Communications Planning

Publication Planning

Medical and Scientific Communications

Scientific Platform Planning

Competitive Publications Analysis

Regulatory *

Labeling & Promotions

Labeling Strategy Development

Core Data Sheet Management

Maintenance & Renewals

Variations & Supplements

Post-Approval Safety Reporting

Promotional Material Compliance

Compliance

189

Regulatory Compliance

117

Dossier & Application Development

Pre-Submission Advisory Meetings

eCTD Publishing & Validation

Agency Meeting Support

Show More (1)

Structured Content Authoring

Show Less (1)

Transparency & Disclosure

Clinical Disclosure

Clinical Transparency

Commercialization *

Customer Engagement

Patient Engagement

Patient Facing Solution Design

Patient Journey Analysis

Omnichannel Optimization

Strategic Account Management

Show More (1)

Retention Program Effectiveness

Show Less (1)

Brand Planning & Activation

Campaign Concept Testing

Multi-Channel Campaign Launch

Brand Vision & Positioning

Market Access & Policy *

Government Policy

Legislative Monitoring

Advocacy Management

Global Market Access

Payer Evidence Generation

Pricing Strategy

Reimbursement Consulting

Payer Relationship Management

Launch Sequencing

Pharmacovigilance *

Safety Systems

Safety Database Hosting

Signal Detection

Case Processing

Safety Data Intake & Triage

Aggregate Reporting

Show More (3)

Safety Data Analytics

Safety Signal Evaluation

Literature Searching

Show Less (3)

Risk Management

Safety Communications

Risk Evaluation & Minimization

Risk Management Evaluation

Finance & Investment *

Financial Services

Investment Performance Analytics

Revenue Forecasting & Planning

Billing & Reporting Operations

Internal Audit Support

Investment Banking

Buy & Sell Side Advisory

Capital Raising & Financing

Investor Relations

Quality & Mfg *

Facilities & Equipment

Equipment Maintenance

Facility Maintenance Programs

Facility Security Management

Deviation Investigations

Calibration & PM Programs

Testing & Release

Stability Program Testing

Batch Release Testing

Raw Material Testing

Quality Management

Deviation Investigation

Corrective Action Verification

Quality Process Governance

Production & Supply Chain

Storage & Distribution

Labeling & Packaging

Clinical & Commercial Production

Clinical Research *

Real World Data Research

Data Standardization & Curation

Late Phase Data Curation

Analytics Methods Development

Lifecycle Evidence Generation

Real World Evidence

Show More (2)

Evidence Prioritization

Observational Research

Show Less (2)

Study Operations & Management

133

Site Contracting & Payments

Study Tracking & Analytics

Site Relationship Management

Trial Implementation

Site Identification & Activation

Show More (1)

Patient Recruitment

Show Less (1)

Clinical Reporting

Clinical Study Report Writing

Abstract & Poster Development

Manuscript Development

Product Development

264

Clinical Research Network Development

Analytical Methods Development

Clinical Research

158

Clinical Trial Material Supply

Clinical Trials

113

Show More (4)

Drug Product Manufacturing

Submissions Management

Formulation Development

Document Management

Show Less (4)

Trial Design & Planning

Protocol Feasibility Planning

Statistical Analysis Planning

Enrollment Analytics

Patient Recruitment Planning

Data Management Planning

Show More (1)

Software

Show Less (1)

Technology & Operations *

Automation & Efficiency

Lab Automation Systems

Clinical Data Automation

Supply Chain Automation

Data & Analytics

152

Data Curation

Artificial Intelligence

Data Visualization

Advanced Analytics

Early Development

Clinical Trial Management Systems

Clinical Supply Chain Automation

Digital Health Solutions

103

Managed Services

Global Connectivity

5G Infrastructure

mHealth Applications

Patient Portals

Show More (3)

Blockchain Applications

Telemedicine Platforms

Wearables & Sensors

Show Less (3)

Operations

Medical Writing

Management Consulting

Other

Human Resources & Talent Acquisition

Public Relations

Show More (7)

Communications

Operations Management

Marketing

Product/Service

Communications & Corporate Affairs

Content Creation & Development

Medical Information Services

Show Less (7)

Informatics Infrastructure

Data Storage Platforms

Data Security Solutions

Cloud Computing Systems

2 3

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Medical Affairs *

Scientific Communications Development

Medical Writing

Payer Advisory Board Strategy

Market Access Advisory Panels

Strategic Stakeholder Engagement

KOL Relationship Management

Advisory Board Strategy

Stakeholder Influence Mapping

Defining the Value of Medical Affairs

Evidence Generation

103

Clinical Trial Concepts

Internal Medical Education

Health Economics Modeling

Patient Journey Mapping

Research Gap Analysis

Strategic Communications Planning

Publication Planning

Medical and Scientific Communications

Scientific Platform Planning

Competitive Publications Analysis

Regulatory *

Labeling & Promotions

Labeling Strategy Development

Core Data Sheet Management

Maintenance & Renewals

Variations & Supplements

Post-Approval Safety Reporting

Promotional Material Compliance

Compliance

189

Regulatory Compliance

117

Dossier & Application Development

Pre-Submission Advisory Meetings

eCTD Publishing & Validation

Agency Meeting Support

Show More (1)

Structured Content Authoring

Show Less (1)

Transparency & Disclosure

Clinical Disclosure

Clinical Transparency

Commercialization *

Customer Engagement

Patient Engagement

Patient Facing Solution Design

Patient Journey Analysis

Omnichannel Optimization

Strategic Account Management

Show More (1)

Retention Program Effectiveness

Show Less (1)

Brand Planning & Activation

Campaign Concept Testing

Multi-Channel Campaign Launch

Brand Vision & Positioning

Market Access & Policy *

Government Policy

Legislative Monitoring

Advocacy Management

Global Market Access

Payer Evidence Generation

Pricing Strategy

Reimbursement Consulting

Payer Relationship Management

Launch Sequencing

Pharmacovigilance *

Safety Systems

Safety Database Hosting

Signal Detection

Case Processing

Safety Data Intake & Triage

Aggregate Reporting

Show More (3)

Safety Data Analytics

Safety Signal Evaluation

Literature Searching

Show Less (3)

Risk Management

Safety Communications

Risk Evaluation & Minimization

Risk Management Evaluation

Finance & Investment *

Financial Services

Investment Performance Analytics

Revenue Forecasting & Planning

Billing & Reporting Operations

Internal Audit Support

Investment Banking

Buy & Sell Side Advisory

Capital Raising & Financing

Investor Relations

Quality & Mfg *

Facilities & Equipment

Equipment Maintenance

Facility Maintenance Programs

Facility Security Management

Deviation Investigations

Calibration & PM Programs

Testing & Release

Stability Program Testing

Batch Release Testing

Raw Material Testing

Quality Management

Deviation Investigation

Corrective Action Verification

Quality Process Governance

Production & Supply Chain

Storage & Distribution

Labeling & Packaging

Clinical & Commercial Production

Clinical Research *

Real World Data Research

Data Standardization & Curation

Late Phase Data Curation

Analytics Methods Development

Lifecycle Evidence Generation

Real World Evidence

Show More (2)

Evidence Prioritization

Observational Research

Show Less (2)

Study Operations & Management

133

Site Contracting & Payments

Study Tracking & Analytics

Site Relationship Management

Trial Implementation

Site Identification & Activation

Show More (1)

Patient Recruitment

Show Less (1)

Clinical Reporting

Clinical Study Report Writing

Abstract & Poster Development

Manuscript Development

Product Development

264

Clinical Research Network Development

Analytical Methods Development

Clinical Research

158

Clinical Trial Material Supply

Clinical Trials

113

Show More (4)

Drug Product Manufacturing

Submissions Management

Formulation Development

Document Management

Show Less (4)

Trial Design & Planning

Protocol Feasibility Planning

Statistical Analysis Planning

Enrollment Analytics

Patient Recruitment Planning

Data Management Planning

Show More (1)

Software

Show Less (1)

Technology & Operations *

Automation & Efficiency

Lab Automation Systems

Clinical Data Automation

Supply Chain Automation

Data & Analytics

152

Data Curation

Artificial Intelligence

Data Visualization

Advanced Analytics

Early Development

Clinical Trial Management Systems

Clinical Supply Chain Automation

Digital Health Solutions

103

Managed Services

Global Connectivity

5G Infrastructure

mHealth Applications

Patient Portals

Show More (3)

Blockchain Applications

Telemedicine Platforms

Wearables & Sensors

Show Less (3)

Operations

Medical Writing

Management Consulting

Other

Human Resources & Talent Acquisition

Public Relations

Show More (7)

Communications

Operations Management

Marketing

Product/Service

Communications & Corporate Affairs

Content Creation & Development

Medical Information Services

Show Less (7)

Informatics Infrastructure

Data Storage Platforms

Data Security Solutions

Cloud Computing Systems

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Headquarters

10001 New Hampshire Ave, Silver Spring, MD 20903-1707, USA

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