KM Pharmaceutical Consulting LLC

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

Project Management

Manages a project from pre-clinical to clinical to NDA
Manages clinical studies
Drafts Investigator’s Brochure
Drafts protocol and Informed Consent Form
Organizes Medical Advisory Board and DSMB
Selects and supervises the best CROs for the project
Selects study sites
Organizes Investigator Meetings
Trains CROs and sites
Reviews data on an ongoing basis
Manages the budget and timeline
Drafts the final study report
Manages preclinical studies
Prepares and coordinate FDA meetings
"Rescues” a project

Strategic Consulting Group Services

Assists in defining a comprehensive strategic drug development plan
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 on 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.