Our consultants have varied expertise in all aspects of quality and compliance, from conducting gap analysis, PAI readiness and mock inspections, to developing and implementing comprehensive inspection responses and corrective action plans. We provide straightforward , comprehensive solutions that can be executed effectively and efficiently. Our approach to corrective action realization will help you successfully remediate compliance issues and provide a strong technical voice to inspection observations, warning letters, field alerts, and other regulatory communications.
Validation Services & Solutions
We specialize in the preparation and execution of validation and compliance documents for equipment, facilities, utilities, processes, analytical methods and instruments. Additionally our experts can assist your operation in developing master validation and cleaning plans and training your personnel to increase employee capital.
We provide strategic advice on filing strategies to prevent costly delays in regulatory approval. Our regulatory experts can assist with review and preparation of product submissions,DMFs, eCTD submissions, pharmacovigilance, annual reports, and recall and regulatory affairs management.
We design and provide training specific to your organization’s needs that ensure personnel are qualified to conduct operations in accordance with internal and regulatory requirements.
- cGMP Training
- Good Documentation Practices
- Quality Systems
- Aseptic Gowning and Behavior
- Operational Procedures
- Out of Specification Procedures
- FDA Enforcement Trends
- Prescription Drug Market Act