Start-ups and established companies which want a hands-on and customized approach, from setting up of a customized Quality System through development of documents for your project, to final implementation and training.

Representative, previous projects are listed below:

  • Mock FDA audit
  • Clinical Audit of the CRO and TMF
  • Quality System Internal Audit
  • Supplier Audits
  • Batch Record Review and Release
  • Stability Protocol and Report review, including expiration dating
  • Design Control Management and Training
  • Risk Analysis and Risk Management
  • Validation Support
  • Deviations and non-conformances
  • Corrective Actions
  • Complaint Management
  • Recalls and regulatory compliance

In addition to receiving the applicable procedures from the “In-The-Box” solution(s), individual and group training, hands-on work and deliverables are provided virtually or at the facility, as appropriate.