Collective BioMarket Consulting, LLC Team Knowledge and Experience

The BioMarket Consulting, LLC Team is led by industry veterans who are committed to advancing biomedical, molecular diagnostic and life science products by bringing their collective experience in sales, marketing, technical writing, regulatory, commercial, reimbursement and scientific development into early stage product creation.

In Vitro Diagnostics

BioMarket Consulting, LLC has significant experience with in vitro diagnostics products, including traditional in vitro diagnostic assays, molecular diagnostics and personalized medicine, biomarker development, and conversion of laboratory developed tests (LDTs) to 510(k) submissions or PMA submissions. We provide FDA regulatory consulting to companies in the in vitro diagnostics industry.

BioMarket Consulting, LLC helps develop and implement customized regulatory strategies designed to optimize the development of in vitro diagnostics products. Our FDA regulatory consulting services include preparing the overall product development plan, creating a customized regulatory strategy, and submission of 510(k)s.

In Vitro Diagnostics Products

BioMarket Consulting, LLC has regulatory and clinical research experience in the following diagnostic areas:

Types of Assays

  • ASRs
  • Biomarkers
  • CLIA Waived Tests
  • Combination Products
  • Companion Diagnostics
  • Drug-of-Abuse Assays
  • Genetic Testing
  • High Throughput Testing
  • IVDMIA
  • LDTs
  • Molecular Diagnostics
  • POC Testing
  • Proteomics

 

Technology Expertise

  • Multiplexing
  • PCR, Real Time PCR, Reverse Transcriptase PCR
  • MicroRNA and siRNA Detection
  • DNA and RNA Expression Assays
  • Immunoassays
  • Immunohistochemistry
  • Microarrays
  • Electrochemiluminescence
  • ELISA
  • FISH and SKY
  • Controls and Calibrators

 

Intended Uses

  • Screening
  • Prognostic
  • Theranostic
  • Diagnostic
  • Monitoring
  • CLIA Laboratory
  • CLIA waiver

 

Therapeutic Expertise

  • Cardiology
  • Clinical Chemistry
  • Endocrinology
  • Genetic Disorders/Diseases
  • Hematology
  • Immunology
  • Infectious Diseases
  • Obstetrics/Gynecology
  • Oncology
  • Opthalmology
  • Orthopedics
  • Respiratory
  • Toxicology

 

Medical Devices

As medical device consultants, BioMarket Consulting, LLC understands medical device regulation, the conduct of medical device clinical trials, and quality assurance within the medical device industry.

BioMarket Consulting, LLC has experience in medical device consulting for products in the following areas:

  • Anatomic pathology
  • Cardiovascular
  • Cancer genetics
  • Clinical Laboratory
  • DNA probe
  • Elemental analysis
  • FISH
  • Flow Cytometry
  • Gastroenterology
  • General Devices
  • General Hospital
  • Hematology
  • Immunodiagnostics
  • ImmunoHistoChemistry stains
  • Infection Control
  • Mammography
  • Microarray
  • mi-RNA
  • Molecular & Clinical Diagnostics
  • Multiplexing
  • Nanotechnology
  • Neurological
  • Obstetrical and Gynecological
  • Oncology
  • Ophthalmic, Ear, Nose and Throat
  • Orthopedics
  • Particle & Cell Characterization
  • Personal Use
  • Pharmacogenomics
  • Physical Medicine
  • Radiological
  • Reproductive
  • Restorative Devices
  • RT-PCR
  • SNPs
  • Urology and Lithotripsy Devices