Clinical Consulting

Advancing Products Most Efficiently to Approval

From early- through late-stage clinical development, our team helps you define and execute an optimal strategy to ensure regulatory compliance of clinical trials.

Clinical success requires proper generation of evidence and essential documents for regulatory approval. Our team will help you prepare for pre-BLA meetings, compile clinical trial study integrated safety and efficacy summaries, conduct GMP pre-approval mock inspections, write and submit your marketing application, and proactively refine your regulatory strategy in line with your selected pathway as development progresses.

Our clinical consulting services encompass:

  • Regulatory Strategy Operations
  • Regulatory and Clinical Strategy
  • Lifecycle Management
  • FDA/Agency Meeting Preparation
  • Advertising & Promotion
  • Project Management
  • Process Improvement & Implementation
  • Data Integrity Remediation
  • Quality Systems Design, Strategy and Implementation
  • Data Integrity
  • Quality IT Systems
  • Support to Implement New/Revised Standards & Regulations
  • FDA/EMA/Health Authority Agency Intelligence
  • Coordination with Regulatory Counsel
  • Third-Party Support
  • Interim Executive Leadership
  • Interim Executive Staffing
  • Interim Subject Matter Experts & Staffing
  • Staff Training
  • Auditing and Assessment
  • Supplier Assessments
  • Clinical Study Design, Synopsis Preparation & Protocol Writing
  • Meeting Package Preparation
  • GCP Inspection
  • Pharmacovigilance
  • SAE Report: 7-Day and 15-Day SUSAR
  • Protocol Amendment
  • PI Change/Addition/Search
  • Annual Report
  • ICF and IB Writing

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