FDA 483 Response- & Compliance
Analytical Services
Environmental Monitoring Support
Risk Analysis
Technical Scientific Assistance
Audit Support
Facility Design & Validation
17025 Calibration Services
Isolator Installation Support
Streamline Aseptic Efficiency Now
Responding to FDA 483s, inspections, Warning Letters and other compliance issues, meeting with FDA to resolve disputes, implementing corrective and protective action (CAPA) programs, and assisting with “a third-party role under a consent decree”
Document preparation and review (including NDAs, INDs, ANDAs, NADAs, and DMFs)
Continuous Improvement
Risk Assessment and Risk Management for production areas (sterile and not sterile)
Environmental Monitoring process and solutions
Data Governance and Data Integrity
Compliance with adverse drug event (ADE) management/reporting including process deviation management
Review of product labeling, advertising/promotional materials for regulatory compliance
Regulatory affairs consulting with strategic assistance
Preparation of protocols, reports, policies, etc.
Training on FDA and EMA -related topics (including fully custom programs to meet client needs)
SOP Review
Assistance with regulatory activities including pre- and post-approval submissions, strategic planning, and FDA/EMA meeting preparation
Implementation and support in their validation of alternative microbiological methodologies in pharma industries
Quality by Design strategy
Support in EU GMPs Annex 1:2022 assessment and compliance (gap analysis and remediations plans)
Strategies, documentation and support (Validation and regulatory submission) for the implementation of alternative microbiological solutions/equipment
