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Pharmaceutical Consulting Services

You may be a Pharmaceutical Company, a Virtual Company, a Research unit or Academia who could well benefit from my extensive portfolio of services based on over 30 years experience of early drug development.

Regulatory

  • Clinical Overview
  • Expert Reports
  • Representation at meetings with Competent Authority (CA)
  • Handling questions from CA

Training

  • GCP
  • Therapeutic
  • Pharmaceutical Medicine
  • Clinical Science
Pharaceutical Consultant

Clinical Pharmacology

  • Feasibility
  • Advice regarding MHRA inspections
  • Advice on First in Human (FIH) studies
  • Advice on EAG (High risk) molecules
  • Biologicals
  • Vaccines
  • Pharmacodynamics and surrogate markers
  • Selection of CRO and Phase I unit and placing of studies
  • Ethics Committee submissions
  • CTA submissions
  • Protocol design and writing
  • DSMBs
  • Bioavailability and bioequivalence
  • Interaction studies
  • Toxicology review
  • 24 hour medical cover
  • Report review
  • Access to
    • Clinical Writing
    • CRAs
    • Data Management and statistics
    • Pharmacokinetics