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Scientific Communications Development

Medical Writing

Payer Advisory Board Strategy

Market Access Advisory Panels

Strategic Stakeholder Engagement

KOL Relationship Management

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Stakeholder Influence Mapping

Defining the Value of Medical Affairs

Evidence Generation

103

Clinical Trial Concepts

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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

187

Regulatory Compliance

117

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Pre-Submission Advisory Meetings

eCTD Publishing & Validation

Agency Meeting Support

Show More (1)

Structured Content Authoring

Show Less (1)

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Clinical Transparency

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Patient Engagement

Patient Facing Solution Design

Patient Journey Analysis

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Multi-Channel Campaign Launch

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Legislative Monitoring

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Reimbursement Consulting

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Signal Detection

Case Processing

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Literature Searching

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Facility Maintenance Programs

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Deviation Investigation

Corrective Action Verification

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Labeling & Packaging

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Real World Evidence

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Evidence Prioritization

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Study Operations & Management

133

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Clinical Study Report Writing

Abstract & Poster Development

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261

Clinical Research Network Development

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Clinical Research

156

Clinical Trial Material Supply

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110

Show More (4)

Drug Product Manufacturing

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Show Less (4)

Trial Design & Planning

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Statistical Analysis Planning

Enrollment Analytics

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Lab Automation Systems

Clinical Data Automation

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150

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Advanced Analytics

Early Development

Clinical Trial Management Systems

Clinical Supply Chain Automation

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101

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About

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Regulatory Compliance

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940 West Valley Rd., Suite 1302, Wayne, PA 19087, USA

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Global Regulatory and Submission Experts Offering Over 30 Years of Insight

For over

decades, this international consulting firm has provided strategic guidance and deliverables to support clients through the entire drug development process - from preclinical to clinical trials, data analysis, regulatory submissions and more. With expertise spanning numerous therapeutic areas, they offer comprehensive contract research and submission services including CDISC conversion, eCTD publishing and US agent representation. Their consulting integrates evaluations across nonclinical, clinical and CMC disciplines to identify development gaps and regulatory strategies. Services range from trial design, pharmacology reviews, dataset coding, IND/NDA authoring, FDA briefing books, due diligence and beyond.

Global Regulatory and Submission Experts Offering Over 30 Years of Insight

For over

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Global Regulatory and Submission Experts Offering Over 30 Years of Insight

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