Services

Regulatory

  • Submissions (510k - IDE - PMA)

  • FDA US Agent Representation

  • FDA Liaison

  • 483 Responses

  • GMP/ISO Compliance Audits

  • QSR/ISO Audits

  • Consent Decree Resolution

  • Due Diligence Audits

  • QSR and cGMP Training Programs

  • Expert Witness Testimony

Quality Assurance

  • Systems Development for FDA QSR and ISO Requirements

  • Supplier Audits for Quality Capabilities and QSR/cGMP/ISO Compliance

  • Software and Process Validation

  • Design History File Auditing

  • Design Control

  • Risk Analysis 

Scientific

  • Clinical Trial Monitoring

  • Sterilization Validation and Sterilizer Selection/Qualification

  • Technical Writing

  • Aseptic Process Problem Resolution

Other

  • Organizational Planning for Quality and Compliance

  • Personnel Recruitment and Selection

  • GAP Analysis for ISO and FDA Compliance

  • Research and Development Project Management

  • Packaging Design 

  • Packaging Equipment Selection and Validation

  • Packaging Suitability and Adequacy of Validation