Invite Supplier

Possible Duplicates

Update Company Details

Terms and Conditions

Available Companies

Select the listing you wish to view or edit.

Video Recommendation

Home Suppliers FDA CDER Small Business and Industry Assistance (SBIA) Locations

FDA CDER Small Business and Industry Assistance (SBIA)

Message
Recommend
Add to My Suppliers

Claim Listing
Report Page
Visit Website

Book Appointment/Scheduler URL

Overview Activity & Updates Locations Contacts

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 *

Clinical Reporting

Abstract & Poster Development

Clinical Study Report Writing

Manuscript Development

Product Development

260

Analytical Methods Development

Clinical Research

157

Clinical Research Network Development

Clinical Trial Material Supply

Clinical Trials

110

Show More (4)

Document Management

Drug Product Manufacturing

Formulation Development

Submissions Management

Show Less (4)

Real World Data Research

Analytics Methods Development

Data Standardization & Curation

Evidence Prioritization

Late Phase Data Curation

Lifecycle Evidence Generation

Show More (2)

Observational Research

Real World Evidence

Show Less (2)

Study Operations & Management

129

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

Data Management Planning

Enrollment Analytics

Patient Recruitment Planning

Protocol Feasibility Planning

Software

Show More (1)

Statistical Analysis Planning

Show Less (1)

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

Show More (1)

Strategic Account Management

Show Less (1)

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

Launch Sequencing

Payer Evidence Generation

Payer Relationship Management

Pricing Strategy

Reimbursement Consulting

Government Policy

Advocacy Management

Legislative Monitoring

Medical Affairs *

Defining the Value of Medical Affairs

Evidence Generation

102

Clinical Trial Concepts

Health Economics Modeling

Internal Medical Education

Patient Journey Mapping

Research Gap Analysis

Scientific Communications Development

Market Access Advisory Panels

Medical Writing

Payer Advisory Board Strategy

Strategic Communications Planning

Competitive Publications Analysis

Medical and Scientific Communications

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

Aggregate Reporting

Case Processing

Literature Searching

Safety Data Analytics

Safety Data Intake & Triage

Show More (3)

Safety Database Hosting

Safety Signal Evaluation

Signal Detection

Show Less (3)

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

185

Agency Meeting Support

Dossier & Application Development

eCTD Publishing & Validation

Pre-Submission Advisory Meetings

Regulatory Compliance

117

Show More (1)

Structured Content Authoring

Show Less (1)

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

146

Advanced Analytics

Artificial Intelligence

Data Curation

Data Visualization

Digital Health Solutions

100

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 (7)

Marketing

Medical Information Services

Medical Writing

Operations Management

Other

Product/Service

Public Relations

Show Less (7)

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

Upload or Edit Image

Member Perk

Perk Name

Expiration Date

Description

Terms & Condition

Custom Confirmation Message Redirect Website

Redirect Website URL

Notify me of any claims

a Refer-a-Friend Campaign

Referral Name

Expiration Date

Description

Terms & Condition

Projects

1 3

Project Name

Description

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 *

Clinical Reporting

Abstract & Poster Development

Clinical Study Report Writing

Manuscript Development

Product Development

260

Analytical Methods Development

Clinical Research

157

Clinical Research Network Development

Clinical Trial Material Supply

Clinical Trials

110

Show More (4)

Document Management

Drug Product Manufacturing

Formulation Development

Submissions Management

Show Less (4)

Real World Data Research

Analytics Methods Development

Data Standardization & Curation

Evidence Prioritization

Late Phase Data Curation

Lifecycle Evidence Generation

Show More (2)

Observational Research

Real World Evidence

Show Less (2)

Study Operations & Management

129

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

Data Management Planning

Enrollment Analytics

Patient Recruitment Planning

Protocol Feasibility Planning

Software

Show More (1)

Statistical Analysis Planning

Show Less (1)

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

Show More (1)

Strategic Account Management

Show Less (1)

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

Launch Sequencing

Payer Evidence Generation

Payer Relationship Management

Pricing Strategy

Reimbursement Consulting

Government Policy

Advocacy Management

Legislative Monitoring

Medical Affairs *

Defining the Value of Medical Affairs

Evidence Generation

102

Clinical Trial Concepts

Health Economics Modeling

Internal Medical Education

Patient Journey Mapping

Research Gap Analysis

Scientific Communications Development

Market Access Advisory Panels

Medical Writing

Payer Advisory Board Strategy

Strategic Communications Planning

Competitive Publications Analysis

Medical and Scientific Communications

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

Aggregate Reporting

Case Processing

Literature Searching

Safety Data Analytics

Safety Data Intake & Triage

Show More (3)

Safety Database Hosting

Safety Signal Evaluation

Signal Detection

Show Less (3)

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

185

Agency Meeting Support

Dossier & Application Development

eCTD Publishing & Validation

Pre-Submission Advisory Meetings

Regulatory Compliance

117

Show More (1)

Structured Content Authoring

Show Less (1)

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

146

Advanced Analytics

Artificial Intelligence

Data Curation

Data Visualization

Digital Health Solutions

100

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 (7)

Marketing

Medical Information Services

Medical Writing

Operations Management

Other

Product/Service

Public Relations

Show Less (7)

2 3

Select multiple images

Crop Image

Upload or Edit Image

Add Image Caption

Add Color

Select Color:

Create Featured Content

Use this to post high quality, thought leadership content (inbound marketing). When members view this content, they will need to agree to share their info with you before they can download the shared file.

Headline/Title (0/150 chars)

Type of Content

Event Date

Content Image

We support most image formats, including .webp, .jpg, gif, etc. Optimal image size should be 400x400 pixels.

Overview (0/750 chars)

Files/Destination

Upload the featured content files that members will be provided after agreeing to share their contact information. Alternatively, if you wish to send them to a third - party webpage, then enter the URL of that webpage.

Upload File

Embed Code

URL

Use this option if you wish to send the user to a specific URL.

If you don't have the source file for a video, then you can alternatively use an embed code and we'll display it in a pop-up.

This is the recommended option. Typically this would be a pdf for a document or a .mp4 or similar file for webinars or video recordings etc.

Category Selection:

No categories match your search criteria.

Clinical Research *

Clinical Reporting

Abstract & Poster Development

Clinical Study Report Writing

Manuscript Development

Product Development

260

Analytical Methods Development

Clinical Research

157

Clinical Research Network Development

Clinical Trial Material Supply

Clinical Trials

110

Show More (4)

Document Management

Drug Product Manufacturing

Formulation Development

Submissions Management

Show Less (4)

Real World Data Research

Analytics Methods Development

Data Standardization & Curation

Evidence Prioritization

Late Phase Data Curation

Lifecycle Evidence Generation

Show More (2)

Observational Research

Real World Evidence

Show Less (2)

Study Operations & Management

129

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

Data Management Planning

Enrollment Analytics

Patient Recruitment Planning

Protocol Feasibility Planning

Software

Show More (1)

Statistical Analysis Planning

Show Less (1)

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

Show More (1)

Strategic Account Management

Show Less (1)

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

Launch Sequencing

Payer Evidence Generation

Payer Relationship Management

Pricing Strategy

Reimbursement Consulting

Government Policy

Advocacy Management

Legislative Monitoring

Medical Affairs *

Defining the Value of Medical Affairs

Evidence Generation

102

Clinical Trial Concepts

Health Economics Modeling

Internal Medical Education

Patient Journey Mapping

Research Gap Analysis

Scientific Communications Development

Market Access Advisory Panels

Medical Writing

Payer Advisory Board Strategy

Strategic Communications Planning

Competitive Publications Analysis

Medical and Scientific Communications

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

Aggregate Reporting

Case Processing

Literature Searching

Safety Data Analytics

Safety Data Intake & Triage

Show More (3)

Safety Database Hosting

Safety Signal Evaluation

Signal Detection

Show Less (3)

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

185

Agency Meeting Support

Dossier & Application Development

eCTD Publishing & Validation

Pre-Submission Advisory Meetings

Regulatory Compliance

117

Show More (1)

Structured Content Authoring

Show Less (1)

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

146

Advanced Analytics

Artificial Intelligence

Data Curation

Data Visualization

Digital Health Solutions

100

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 (7)

Marketing

Medical Information Services

Medical Writing

Operations Management

Other

Product/Service

Public Relations

Show Less (7)

Crop Image

Upload or Edit Image

;

Featured Video

Video Type

Embeded Code

Upload Video

Video File Maximum size: 400MB

Embedded Code

Video Title

Video Description

Send Message

From :

Subject

Edit Featured Video

Video Title

Video Description

Add new card

Name on Card

Change Featured Content Owner

;

Send Message

E-mail address

Set New Publish Date

;

Crop Image

Upload or Edit Image

Crop Image

Upload or Edit Image

About

Regulatory

Compliance

Agency Meeting Support, Dossier & Application Development

2 More

Pre-Submission Advisory Meetings , Regulatory Compliance

2 Less

Labeling & Promotions

Labeling Strategy Development

Contacts

3 Contacts

Headquarters

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