Nyandee Quality Group LLC offers bilingual (English and Spanish) services
Regulatory Review and Compliance
- Development/enhancement of robust quality management system (QMS) in compliance with applicable standard such as cGMP, ISO 9000 series etc.
- Review and evaluations of QMS for operations, audit preparation and or regulatory (USFDA, WHO, NRA) audit response
- Generation of gap analysis and implementation audit response plan for client and regulatory audits
Clinical Regulatory Study Management
- Clinical trial management
- Study site vetting and selection
- Study site initiation and closing visits
- Study documents (protocols, informed consent forms, study and laboratory manuals) review
- Onsite and remote monitoring and monitoring report review
Documentation Generation and Review
- Creation of standard operation procedure (SOP) and QA policies
- Review and gap analysis of quality documents and reports.
- Document Control
- Review of compliance with electronic records requirement such 21CFR Part 11
Independent Verification and Validation
- Continuous improvements and monitoring - onsite & desktop auditing Certified Quality Auditor (CQA) as per ISO 9000 standards.
- Audit reports and analysis
- Corrective action preventative action (CAPA) planning and implementation
- Data review
- Document control
Process Improvement and Monitoring
- Gap analysis and cost reduction of processes and or key performance indicators (KPIs)
- CAPA process improvement
- Evaluation of process for establishing and maintaining SOPs.
- Continuous process improvement evaluation to streamline and optimize processes and procedures to drive cost and efficiency.
