IND Directions, LLC

 

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IND Directions, LLC, offers comprehensive drug development services to the biotechnology and pharmaceutical industry. IND Directions is located in Catharpin, Virginia, in close proximity  to the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
 
IND Directions services span all areas of product development  including preclinical, manufacturing, regulatory, quality, medical writing, and clinical development.
 
The primary goal of IND Directions is to understand your drug development needs and provide you with the level of assistance you require to accomplish your goals and meet your project milestones.
 
IND Directions can assist your organization by “filling in the gaps” in managing and conducting preclinical, manufacturing, regulatory, and clinical aspects of your development program, thus becoming an extension of your project team.
 

Strategic Planning

  • Manufacturing
  • Preclinical Studies
  • Clinical Studies
  • Timelines
  • Budgets

Preclinical Outsourcing & Management

  • CRO Selection & Qualification
  • Protocol Design
  • Study Management
  • Study Monitoring
  • Report Preparation

Clinical Trial Strategy

  • Clinical Development Plans
  • Clinical Trial Designs & Interpretation
  • Phase 1, 2, 3 Protocols
  • Principal Investigator Identification

Regulatory Submissions

  • FDA Liaison
  • Pre-IND, IND Submissions
  • NIH RAC Submissions
  • Orphan Drug Applications

CMC & Manufacturing Outsourcing

  • Contract Manufacturer Identification
  • Drug Substance & Drug Product Management
  • Preclinical & Clinical Supply Production
  • Formulation Development
  • Bioanalytical Analyses

Quality Services

  • GLP, GMP, GCP Audits
  • Contractor Audits
  • Quality System Reviews


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