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Sample Projects

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Quality System Implementations (including comprehensive Consent Decree and Warning Letter remediations) for:
  • IVD and investigational product developers and manufacturers
  • Medical device developers and manufacturers (e.g.,endovascular products, surgical devices, imaging systems, cardiac monitoring systems, instrumentation)
  • Software medical device developers and manufacturers
  • Dialysis systems and dialysate manufacturers
  • Finished pharmaceutical manufacturers
  • Bulk drug/active pharmaceutical ingredient (API) manufacturers
  • Sunscreen/OTC manufacturers
  • Contract testing laboratories
Compliance Audits for:
  • Medical device and IVD manufacturers (Quality Systems compliance, design control processes, Part 11)
  • Software manufacturers (Design control processes, validation practices, Part 11)
  • Finished pharmaceutical and bulk drug/active pharmaceutical ingredient (API) manufacturers (Good Manufacturing Practices, Part 11)
  • Contract testing laboratories (Good Laboratory Practices, laboratory GMPs, software validation, Part 11)
  • Bioequivalence audits (generic drug comparatives)
Software Validation, 21 CFR Part 11, and Software Quality Services for:
  • Blood bank software (standalone device)
  • Radiation treatment planning software (accessory device)
  • Chemistry analyzer software (device component)
  • Digital imaging systems software (device component)
  • Automated building management (environmental monitoring) systems (process software)
  • Document management and control software (Quality Systems software)
  • Complaint, defect tracking and CAPA software (Quality Systems software)
  • Data acquisition systems, including clinical data and HPLC analysis (process software)
  • Commercial Off-the-Shelf (COTS) software (process and Quality Systems software)
Clinical Services (Audits, Protocol Review and Medical Summaries) for:
  • Medical devices (examples: neurovascular, cardiovascular and peripheral vascular intervention, gamma-detecting probe, blood filtration system, ovulation indicator)
  • Biological products (examples: monoclonal antibodies, activated lymphocytes, bioadhesives)
  • Topical pharmaceuticals (examples: anti-fungal treatment, acne treatment)
  • Oral pharmaceuticals (examples: anti-MS therapeutic, Parkinson’s disease therapeutic)
FDA Submissions for:
  • Blood bank software [510(k)]
  • Gamma-detecting probe [510(k)]
  • Brachytherapy accessory device [510(k)]
  • Valve suction irrigator [510(k)]
  • Imaging diagnostic system for charged-particle radiation therapy [510(k)]
  • Breast imaging systems [PMA]
  • Radiolabeled monoclonal antibody [IND]
  • Generic topical tretinoin [ANDAs / CMC Sections]
  • Ocular diagnostic solution [505(b)(2)]
  • Active pharmaceutical ingredients [US DMFs]
  • Chemical medical device [US and EC DMFs]
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