Pharmaceutical Quality Assurance
Partnering to Provide Full Quality Assurance Support
We help businesses at all stages develop quality assurance (QA) practices and systems for their entire organization.
We help startups develop internal QA practices for GLP and GMP and oversee outsourced activities performed at CRO/CMOs. We work as your partner to build phase-appropriate QA systems to ensure compliance with regulatory requirements.
We help startups develop internal QA practices for GLP and GMP and oversee outsourced activities performed at CRO/CMOs. We work as your partner to build phase-appropriate QA systems to ensure compliance with regulatory requirements.
For more advanced businesses, we provide additional QA resources to supplement your team’s expertise.
We offer full QA services that are tailored to your needs, providing you with an agile solution to meet your QA challenges.
We offer full QA services that are tailored to your needs, providing you with an agile solution to meet your QA challenges.
| 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 | | |
Quality System Audits to Strengthen Global Compliance
Our Quality Assurance audits are designed to reinforce your QMS and ensure alignment with international regulatory standards, including FDA, EMA, MHRA, Health Canada, and local MOHs. We provide:
- Internal Audits: Reviewing SOPs, documentation, and cross-functional processes.
- Supplier Audits: Evaluating the quality systems of CMOs, CROs, and labs.
- Mock Inspections: Preparing your team for pre-approval inspections and surveillance audits.
These audits support continuous improvement, reduce compliance risk, and ensure you stay inspection-ready. Connect with us to schedule a QMS-focused audit.
