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Service

Consultant Services – Drugs, Biologics, Devices

 

Overview of Services

Manufacturing, Nonclinical, Clinical, Quality, Regulatory

Scientific Consultation

Product and Technology Evaluation, Due Diligence

Study Retrieval

Crisis Management, Rapid Response Cycle

Other Business Support

Risk Management, Translation Services, Writers, Editors

Optimized Drug Development

Streamline Efficiencies and Approvals, Project Management

Regulatory: Strategy and Operations

Regulatory Consultation, Representation at Regulatory Agencies, eCTD Submission

Domestic and International Clinical Management

Clinical Programs, Study Tracking, Data Retrieval

Quality and Compliance Support

GxP management, Audit Support, Corporate Training