Quality and Compliance Staffing

We partner with life science companies, including biotech, pharmaceutical, and medical device firms, to navigate the complexities of the product lifecycle by providing the right talent. This saves you time and resources, allowing you to focus on your core objectives while we manage the staffing process.

Regulatory Compliance – Clinical & Development, Manufacturing, Distribution and Sales & Marketing Cycles

  • Global regulatory strategies (FDA/EU)
  • Compliance audits & gap analyses
  • Mock inspections
  • FDA warning letter responses & remediation
  • Facilities operations review
  • CE Mark

Quality Management Systems – Manufacturing Cycle

  • Quality systems auditing
  • Pre-certification auditing
  • ISO certification readiness
  • Batch records/DMR/DHR
  • CAPA services
  • Vendor/supplier audits
  • MDSAP

Regulatory Affairs – Manufacturing & Distribution Cycles

  • US Class II & III medical device submissions; EU MDR submissions (change amendments, design dossiers)
  • Independent regulatory guidance to product development teams
  • Technical file remediation
  • Complaint handling & recalls
  • Product registrations

Validation – Manufacturing &  Distribution Cycles

  • Validation master plan
  • Process  & product validation
  • Computer systems validation
  • Equipment validation
  • Special processes & procedures
  • Test method validation
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