- Our particular areas of expertise include:
- Initial planning, developing regulatory strategies for, and preparing regulatory submission documents for investigational
and marketed medical products including: INDs, IDEs, BLAs, 510(k)s, and Biologics Master Files
- Conducting GCP, GLP, and GMP audits
- Presenting training sessions on topics such as:
- General
and targeted GXP training
- Compliance expectations for executive
management
- Auditor training
- How to manage an inspection by a regulatory body
- Identification,
development, and implementation of quality systems including:
- Auditing programs
- Corrective and Preventive Action
- Document control and change control
- Electronic document management systems (EDMS)
- Customer Complaint Handling
- Conducting due diligence audits as part of
new project feasibility evaluations
- Assisting with day-to-day
activities
- Writing and executing IQ/OQ/PQ validations test
scripts and other activities
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