Services

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REGULATORY SERVICES

  • Toxicology, Biocompatibility and Chemical Analysis services
  • Laboratory Qualification, Validation and Certification Services
  • GLP, cGMP, QSR and ISO and CE Mark Compliance
  • Submission Development and Coordination (510(k), IDE, IND, BLA, NDA)
  • Regulatory Risk Assessment and Risk Management
  • Labeling Review and Product Claims Substantiation
  • Product Registration and Distribution Strategies
  • International Registrations
  • 510(k), PMA, IND, ANDA and NDA Submissions
  • Medical Device Development
  • Medical Device Registration
  • Technical File Development
  • FDA and Notified Body Liaison services

COMPLIANCE SERVICES

  • Gap Analysis and Compliance Assessment
  • Compliance Training (FDA/ISO/EPA/OSHA/AAMI)
  • Quality Systems Development
  • Quality Manual and Compliance Documentation Development
  • SOP / Procedures Development
  • Internal and Supplier Audits
  • Pre-Inspection planning

MEDICAL DEVICE PRODUCTS: 510(K) CLEARED

Rapid accurate detection In-Vitro Diagnostic devices

  • Infectious Disease Testing
  • Cardiac Enzyme Testing for Emergency Clinical Use
  • Cancer Response Prediction Testing
  • Clinical Toxicological Testing
  • Liver and Kidney Function Testing

Telemedicine

  • Computer applications for clinical diagnosis and data management
  • Visual Acuity Testing
  • Home based use dialysis devices
  • Liver and Kidney Function Testing

Intensive Care, Surgical and Emergency Treatment Devices:

  • Surgical lasers and cautery devices
  • Surgical instruments for cardiac surgery and internal medicine
  • Monitoring devices, leads and telemetry devices
  • AED Cardiac Defibrillators
  • Sterile Surgical Supplies and IV Solutions and packaging

Laboratory Technical Services:

  • Lab / Facility Development & Validation
  • Assay Development
  • Infrastructure Process Development
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