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.