Contact Us Blog

Source Plasma and Blood

Source Plasma and Blood

The human blood and plasma industry plays a critical role in today’s healthcare system. We work with both Plasma Collectors and Device Manufactures including IVD manufactures. We provide comprehensive compliance and remediation services for plasma facilities across the country, including facility auditing, compliance remediation, and site licensing assistance to help clients meet FDA quality system regulations.

Our services include:

Source Plasma and Blood

  • PPTA viral marker reporting
  • CLIA/COLA reporting
  • State regulatory filings
  • Regulatory strategy, assessment and compliance
  • CBER Biological Licensing Applications (BLA) Submissions – including PAS, CBE30, CBE, and Annual Reports submissions
  • Batch record reviews & investigations
  • Validation and qualification
  • Laboratory methods validation
  • Computer/software validation
  • Site remediation
  • On-site training of company quality systems
  • Directive 2002/98/EC