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Regulatory Sciences

FDA Regulatory Consulting

FDA Meeting Consulting Services

FDA Expert Witness Services

European Regulatory Development

European Marketing Authorization Holder (MAH)

European Lifecycle Management

Regulatory Operations

Advertising & Promotional Review

Market Access & Reimbursement Strategy

Nonclinical Development

Medical Device

Clinical Research Solutions

Full-Service CRO

Decentralized Clinical Trials

Embedded Solutions

Global Medical Writing & Transparency

Medical Device

Quality & Compliance

Computer System Validation

GxP Compliance & Auditing

Compliance

Inspection Readiness

Program & Project Management

Commissioning, Qualification & Validation

Clinical Quality Assurance

Medical Device

Cell & Gene Therapy Consulting

Healthcare Compliance Services

Digital Transformation

Pharmacovigilance

Clinical Pharmacovigilance

Post-marketing Pharmacovigilance

Safety Systems

QPPV & LPPV

Case Management

Global Literature Review

Signal Management

Periodic Safety Reports and Risk Management Plans

Global Submissions

Regulatory Intelligence

Medical Information

Global Contact Center Support

Medical Information

Adverse Event Intake & Follow-Up Services

Product Complaint Intake & Follow-Up Services

Patient Support and Commercial Services

Medical Communications, Content Management & Translation

Animal Health Services

REMS & RMP Support

Clinical Trial Support & Concierge Services

FSP Solutions

Clinical Operations

Data Sciences

Biostatistics

Medical Writing & Quality Control

Decentralized Clinical Trials

Digital Transformation

Digital Blueprint

Data Strategy

Technology Services

Validation, Quality & Compliance
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Therapeutic Areas
Therapeutic Areas

Leading with strategy, our model delivers bespoke / custom solutions that deliver results. Our fit-for purpose global solutions span across the full product lifecycle.
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