Services

KM Pharmaceutical Consulting LLC can provide the following services in drug development.

Project Management

  • Manage a project from pre-clinical to clinical to NDA
  • Manage clinical studies
  • Draft Investigator’s brochure
  • Draft protocol and Informed consent form
  • Organize Medical Advisory Board and DSMB
  • Select and supervise the best CROs for the project
  • Select study sites
  • Organize Investigator Meetings
  • Train CROs and sites
  • Review data on an ongoing basis
  • Manage the budget and timeline
  • Draft the final study report
  • Manage preclinical studies
  • Prepare and coordinates FDA meetings
  • "Rescue”a project

Our Strategic Consulting Group Services

  • Assists in defining a comprehensive strategic drug development plans
  • Evaluates the medical and pharmaceutical potential of products in preclinical or early clinical development
  • Identifies the target indication(s)
  • Evaluates formulation strategy
  • Assists in defining a Regulatory strategy from Pre-IND to NDA/BLA
  • Assists in feasibility assessments for clinical programs
  • Interprets both preclinical and clinical data
  • Evaluates preclinical data focusing more particularly the prediction of clinical safety and outcomes
  • Reviews the IND and NDA
  • Evaluates diagnostic technologies and positioning of their applications
  • Assists strategic analyses of competitive products
  • Assists in all aspects of scientific and medical due diligence
  • Assists with IP strategy

Our Regulatory Group provides the following services

  • Regulatory strategy
  • Regulatory intelligence
  • Interaction with regulatory agencies
  • Preparation and coordination of FDA meetings
  • Management of IND/NDA and other regulatory submissions
  • GMP and GCP audits
  • Regulatory operational services as an agent

KM brings together a unique group of world-class experts in a broad range of basic, medical, and pharmaceutical science and technology, as well as in regulatory.