Preclinical Consulting

Optimizing the First Steps to Ultimate Product Approval

A well-defined regulatory strategy is the first step in defining an optimal product development plan, inclusive of clinical and commercial considerations.

Validant works with you, hand-in-hand, to help assess your product’s market potential and ideal indication, define the preclinical data needed to enter the clinic, and develop methodologies to translate easily to future clinical development. Throughout the process, we support the preparation and lifecycle management of INDs, NDAs/BLAs, IDEs, 510(K)s, and PMAs for regulatory agencies.

Turn to our expert team for preclinical support involving:

  • Regulatory Strategy Operations
  • Regulatory and Clinical Strategy
  • Lifecycle Management
  • FDA/Agency Meeting Preparation
  • IND, NDA/BLA, ANDA, IDE, 510(K), PMA Preparation
  • Submissions & Publishing & eCTD
  • CMC Strategy
  • Advertising & Promotion
  • Drug & Device Labeling
  • Regulatory Affairs IT Systems
  • Process Improvement & Implementation
  • Lab Controls and Data Integrity
  • Data Integrity Remediation
  • Interim Subject Matter Experts & Staffing
  • Staff Training
  • Project Management
  • Quality Systems Design, Strategy and Implementation
  • Quality Systems Development
  • Data Integrity
  • Risk Management
  • Design Controls
  • Support to Implement New/Revised Standards & Regulations
  • FDA/EMA/Health Authority Agency Intelligence
  • Coordination with Regulatory Counsel
  • Third-Party Support
  • Auditing and Assessments
  • Supplier Assessments
  • Regulatory Affairs
  • Strategy Guidance & Gap Assessment
  • Preclinical Strategy/Program Design (GLP Toxicology Studies; GLP PK Studies; Non-GLP Pharmacodynamics Studies)
  • Protocol and Report Review for PK/PD/Toxicology
  • Study Report Composition, Review, Authorization & Results Interpretation
  • PK/PD Modeling
  • IB Writing & Preparation
  • Nonclinical Study Report Translation (Chinese/English)

Case Study

Enabling Safe to Proceed Determinations from the FDA on Submitted INDs

See how DataRevive achieved a 100% passing of 32 IND applications over the course of one year.

View the Case Study

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