Mindful Quality
Regulatory compliance consulting firm founded in 2019 that provides cleaning validation, analytical method support, inspection readiness, nitrosamine evaluation, quality systems support, and project management services for pharmaceutical and biotechnology clients.
Industries
Nr. of Employees
small (1-50)
Services
Consulting to design cleaning cycles, develop cleaning validation master plans, protocols, grouping strategies, and corporate/site cleaning procedures to improve efficiency and compliance.
Support for analytical method selection, method development, method transfer, validation protocols/reports/SOPs, and remediation of analytical programs.
Preparation and support for internal, third-party, and regulatory inspections including gap assessments, SME support, interview preparation, and on-site inspection strategy.
Risk assessments, development and validation of nitrosamine detection methods, remediation planning, and third-party de-risking reports for submission to health agencies.
Interim leaders and mentors, auditors, investigators, technical writers, and batch reviewers to support investigations, procedures, batch disposition, and other quality functions.
Project planning, executive status tracking of KPIs and milestones, and aligned execution to keep regulated projects on schedule and within scope.
Consulting to design cleaning cycles, develop cleaning validation master plans, protocols, grouping strategies, and corporate/site cleaning procedures to improve efficiency and compliance.
Support for analytical method selection, method development, method transfer, validation protocols/reports/SOPs, and remediation of analytical programs.
Preparation and support for internal, third-party, and regulatory inspections including gap assessments, SME support, interview preparation, and on-site inspection strategy.
Risk assessments, development and validation of nitrosamine detection methods, remediation planning, and third-party de-risking reports for submission to health agencies.
Interim leaders and mentors, auditors, investigators, technical writers, and batch reviewers to support investigations, procedures, batch disposition, and other quality functions.
Project planning, executive status tracking of KPIs and milestones, and aligned execution to keep regulated projects on schedule and within scope.
Expertise Areas
- Cleaning validation and cleaning process development
- Analytical method development, transfer and validation
- Inspection readiness and regulatory audit support
- Nitrosamine risk assessment and remediation
Key Technologies
- High-performance liquid chromatography (HPLC)
- Gas chromatography (GC)
- Mass spectrometry (MS)
- Total organic carbon (TOC) measurement
News & Updates
Blog post discussing FDA inspection citation data and the continued prominence of cleaning-related citations.
Article on mitigating human variability in manual cleaning through robust training and qualification programs.
Guidance on using health-based exposure limits and alternative approaches when compound-specific HBELs are not available.
Discussion of strategies to improve sample efficiency in analytical method validation.
Company displayed WBENC certification and identifies as a women-owned business.
Blog post discussing FDA inspection citation data and the continued prominence of cleaning-related citations.
Article on mitigating human variability in manual cleaning through robust training and qualification programs.
Guidance on using health-based exposure limits and alternative approaches when compound-specific HBELs are not available.
Discussion of strategies to improve sample efficiency in analytical method validation.
Company displayed WBENC certification and identifies as a women-owned business.