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FDA CDER Small Business and Industry Assistance (SBIA)

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FDA CDER Small Business and Industry Assistance (S...

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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.

Clinical Research *

Clinical Reporting

Abstract & Poster Development

Clinical Study Report Writing

Manuscript Development

Product Development

Analytical Methods Development

Clinical Research

Clinical Trial Material Supply

Clinical Trials

Document Management

Show More (3)

Drug Product Manufacturing

Formulation Development

Submissions Management

Show Less (3)

Real World Data Research

Analytics Methods Development

Data Standardization & Curation

Late Phase Data Curation

Lifecycle Evidence Generation

Observational Research

Study Operations & Management

Patient Recruitment

Site Contracting & Payments

Site Identification & Activation

Site Relationship Management

Study Tracking & Analytics

Trial Design & Planning

Data Management Planning

Enrollment Analytics

Patient Recruitment Planning

Protocol Feasibility Planning

Statistical Analysis Planning

Commercialization *

Brand Planning & Activation

Brand Vision & Positioning

Campaign Concept Testing

Multi-Channel Campaign Launch

Customer Engagement

Omnichannel Optimization

Patient Engagement

Patient Facing Solution Design

Patient Journey Analysis

Retention Program Effectiveness

Finance & Investment *

Financial Services

Billing & Reporting Operations

Internal Audit Support

Investment Performance Analytics

Revenue Forecasting & Planning

Investment Banking

Buy & Sell Side Advisory

Capital Raising & Financing

Investor Relations

Market Access & Policy *

Global Market Access

Payer Evidence Generation

Payer Relationship Management

Reimbursement Consulting

Government Policy

Advocacy Management

Legislative Monitoring

Medical Affairs *

Evidence Generation

Clinical Trial Concepts

Health Economics Modeling

Internal Medical Education

Patient Journey Mapping

Research Gap Analysis

Scientific Communications Development

Market Access Advisory Panels

Payer Advisory Board Strategy

Strategic Communications Planning

Competitive Publications Analysis

Publication Planning

Scientific Platform Planning

Strategic Stakeholder Engagement

Advisory Board Strategy

KOL Relationship Management

Stakeholder Influence Mapping

Pharmacovigilance *

Risk Management

Risk Evaluation & Minimization

Risk Management Evaluation

Safety Communications

Safety Systems

Safety Data Analytics

Safety Data Intake & Triage

Safety Signal Evaluation

Quality & Mfg *

Facilities & Equipment

Calibration & PM Programs

Deviation Investigations

Equipment Maintenance

Facility Maintenance Programs

Facility Security Management

Production & Supply Chain

Clinical & Commercial Production

Labeling & Packaging

Storage & Distribution

Quality Management

Corrective Action Verification

Deviation Investigation

Quality Process Governance

Testing & Release

Batch Release Testing

Raw Material Testing

Stability Program Testing

Regulatory *

Compliance

Agency Meeting Support

Dossier & Application Development

eCTD Publishing & Validation

Pre-Submission Advisory Meetings

Regulatory Compliance

Labeling & Promotions

Core Data Sheet Management

Labeling Strategy Development

Maintenance & Renewals

Post-Approval Safety Reporting

Promotional Material Compliance

Variations & Supplements

Transparency & Disclosure

Clinical Disclosure

Clinical Transparency

Technology & Operations *

Automation & Efficiency

Clinical Data Automation

Lab Automation Systems

Supply Chain Automation

Data & Analytics

Advanced Analytics

Data Curation

Data Visualization

Digital Health Solutions

5G Infrastructure

Blockchain Applications

mHealth Applications

Patient Portals

Telemedicine Platforms

Show More (1)

Wearables & Sensors

Show Less (1)

Early Development

Clinical Supply Chain Automation

Clinical Trial Management Systems

Informatics Infrastructure

Cloud Computing Systems

Data Security Solutions

Data Storage Platforms

Operations

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)

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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.

Clinical Research *

Clinical Reporting

Abstract & Poster Development

Clinical Study Report Writing

Manuscript Development

Product Development

Analytical Methods Development

Clinical Research

Clinical Trial Material Supply

Clinical Trials

Document Management

Show More (3)

Drug Product Manufacturing

Formulation Development

Submissions Management

Show Less (3)

Real World Data Research

Analytics Methods Development

Data Standardization & Curation

Late Phase Data Curation

Lifecycle Evidence Generation

Observational Research

Study Operations & Management

Patient Recruitment

Site Contracting & Payments

Site Identification & Activation

Site Relationship Management

Study Tracking & Analytics

Trial Design & Planning

Data Management Planning

Enrollment Analytics

Patient Recruitment Planning

Protocol Feasibility Planning

Statistical Analysis Planning

Commercialization *

Brand Planning & Activation

Brand Vision & Positioning

Campaign Concept Testing

Multi-Channel Campaign Launch

Customer Engagement

Omnichannel Optimization

Patient Engagement

Patient Facing Solution Design

Patient Journey Analysis

Retention Program Effectiveness

Finance & Investment *

Financial Services

Billing & Reporting Operations

Internal Audit Support

Investment Performance Analytics

Revenue Forecasting & Planning

Investment Banking

Buy & Sell Side Advisory

Capital Raising & Financing

Investor Relations

Market Access & Policy *

Global Market Access

Payer Evidence Generation

Payer Relationship Management

Reimbursement Consulting

Government Policy

Advocacy Management

Legislative Monitoring

Medical Affairs *

Evidence Generation

Clinical Trial Concepts

Health Economics Modeling

Internal Medical Education

Patient Journey Mapping

Research Gap Analysis

Scientific Communications Development

Market Access Advisory Panels

Payer Advisory Board Strategy

Strategic Communications Planning

Competitive Publications Analysis

Publication Planning

Scientific Platform Planning

Strategic Stakeholder Engagement

Advisory Board Strategy

KOL Relationship Management

Stakeholder Influence Mapping

Pharmacovigilance *

Risk Management

Risk Evaluation & Minimization

Risk Management Evaluation

Safety Communications

Safety Systems

Safety Data Analytics

Safety Data Intake & Triage

Safety Signal Evaluation

Quality & Mfg *

Facilities & Equipment

Calibration & PM Programs

Deviation Investigations

Equipment Maintenance

Facility Maintenance Programs

Facility Security Management

Production & Supply Chain

Clinical & Commercial Production

Labeling & Packaging

Storage & Distribution

Quality Management

Corrective Action Verification

Deviation Investigation

Quality Process Governance

Testing & Release

Batch Release Testing

Raw Material Testing

Stability Program Testing

Regulatory *

Compliance

Agency Meeting Support

Dossier & Application Development

eCTD Publishing & Validation

Pre-Submission Advisory Meetings

Regulatory Compliance

Labeling & Promotions

Core Data Sheet Management

Labeling Strategy Development

Maintenance & Renewals

Post-Approval Safety Reporting

Promotional Material Compliance

Variations & Supplements

Transparency & Disclosure

Clinical Disclosure

Clinical Transparency

Technology & Operations *

Automation & Efficiency

Clinical Data Automation

Lab Automation Systems

Supply Chain Automation

Data & Analytics

Advanced Analytics

Data Curation

Data Visualization

Digital Health Solutions

5G Infrastructure

Blockchain Applications

mHealth Applications

Patient Portals

Telemedicine Platforms

Show More (1)

Wearables & Sensors

Show Less (1)

Early Development

Clinical Supply Chain Automation

Clinical Trial Management Systems

Informatics Infrastructure

Cloud Computing Systems

Data Security Solutions

Data Storage Platforms

Operations

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)

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FDA CDER Small Business and Industry Assistance (SBIA)

CDER SBIA is often the first stop for a small pharmaceutical business trying to contact the Agency. Our goal is to help small pharmaceutical business and industry navigate the wealth of information that FDA offers, and to assist in understanding human drug product regulation.

CDER SBIA is often the first stop for a small pharmaceutical business trying to contact the Agency. Our goal is to help small pharmaceutical business and industry navigate the wealth of information that FDA offers, and to assist in understanding human drug product regulation.

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FDA CDER Small Business and Industry Assistance (SBIA)

FDA CDER Small Business and Industry Assistance (S...

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