We Provide Full QA Pharma Support for your Company at Every Stage
including your QA Medical practices to help secure approval for your product
Let’s talk!
Partner with us and we’ll help you to:
- Solve your QA pharma challenges
- Ensure compliance with regulatory organizations
- Secure approval for your product
| Quality Assurance | Early Stage | Pre-clinical | Clinical | Registration | Market |
|---|---|---|---|---|---|
| Build QA Systems Establish quality management systems |  | | |||
| Perform gap assessment for the current Quality Management System (QMS), including computerized systems and data integrity capabilities | | | | ||
| Quality oversight of manufacturing activities | | | | ||
| Quality oversight of QC activities (including support with analytical and bioanalytical method development and review of analytical method qualification/validation protocols and reports) | | | | | |
| Qualification and periodic evaluation of service providers (including onsite/remote audits of CMOs, CROs, Analytical Laboratories, etc.) | | | | | |
| Review and establish quality agreements with service providers. | | | | | |
| Provide ongoing QA support remotely and/or at client’s offices (including master and executed batch records review, batch release, etc.) | | | | | |
| Simulate Inspections. Hold mock inspections to prepare for European and FDA pre-approval inspections | | | |||
| Lead and support inspection readiness and risk assessment processes | | | | ||
| Prepare quality improvement plans | | |
