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.