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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:

  • 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

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The Latest News

What You Need to Know About GDPR

What You Need to Know About GDPR

If you’re a medical device manufacturer planning do to business with the European Union you need to know about the regulatory change that took place in May 2018 that could have operational process and financial implications for your business. The new General Data Protection Regulation (GDPR) contains both existing and new data privacy requirements that, if not met, can result in significant fines of up to 20 million Euro or four percent of annual turnover. Maintaining compliance is required of...
medical device microchip board

Are You a Start-Up? We Can Help.

Last year the US medical device industry achieved over $150 billion in sales, making it one of the most lucrative industries in the country. However, launching a medical device start-up in this highly regulated industry can be fraught with challenges. Medical product start-ups need to minimize regulatory and compliance risk to attract early-stage investors and save money. To complicate matters even more, recent changes in FDA regulations make it more important than ever to limit potential...
MEDIcept

Covering All Angles of Quality Assurance

Every responsible medical device manufacturer is aware that the FDA requires them to establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications – a protocol known as current good manufacturing practices (CGMP). These requirements were written into the original regulation issued back in 1978, which was revised, starting in 1990, into a broader and more consistent quality system (QS) regulation that is in effect today. Of...