QUALIFY, TRAIN & AUDIT YOUR CLINICAL APHERESIS SITES

  • Locate sites with appropriate capabilities
  • Assess site environment and regulatory status
  • Train site on protocols, and cell collection specifications
  • Assist with mock shipments / shipping validations
  • Be present for first collection and infusion
  • Be available for assistance

SUPPLIER AUDITS

  • 510k approved software
  • eQMS
  • Medical Supplies
  • Reagents & Controls
  • Qualification audits for your cellular collection sites (Apheresis Centers, Stem Cell Labs and LN2 Storage Facilities) 
  • Environmental Monitoring
  • Logistical Services (shipper boxes, transport routes, temp monitoring etc.)

STANDARD OPERATING PROCEDURES

  • Complete set of SOPs for new centers
  • Write procedures and validation documents for a new product line
  • Audit and update existing SOPs

REGULATORY

  • Fill the role of Authorized Official
  • Submit Biologics Application Submissions (BLA, PAS, CBE, CBE30, PC, AR, IRB)
  • Determine a Regulatory Path for Your New Biologics Product
  • New Drug Applications
  • Clinical Trials
  • Protocols for IRB
  • FDA, EMA, CLIA, PPTA, AABB, ISO Audit Preparation
  • File Biological Product Deviation Reports (BPDRs)
  • Help You Get Out of a Quality or Regulatory "Pickle" with FDA or EMA/other Regulators

 VALIDATIONS

  • Write, Execute, Review Equipment Validations
  • OPERATIONS
  • Open Specialty Blood Bank or Source Plasma Center
  • Help Create Your Budget (center budgets, project budgets)
  • Evaluate Your Current Processes Make Recommendations for Improvements
  • Evaluate Software and Equipment to Meet Business Needs and Regulatory Requirements
  • Translate Your Business Rules into the Configuration Requirements for Your New Software
  • Set-up Supply Chain
  • Create & Execute Shipper Validations

TRAINING

  • Create & Deliver Training & Education Programs

COMPLIANCE & RISK MANAGEMENT

  • Perform Internal Audits
  • Perform Vendor Audits
  • FMEA Analysis 

RESEARCH & DEVELOPMENT

  • We are Research Experts. Give Us Your Most Challenging Problems and We Will Perform ALL the Research You NEVER want to Have to Do Yourself!!
  • Perform Due Diligence Audits