Quality Consulting Services
Sajjadi Consulting brings technical expertise and broad based experience to organizations involved in the development of complex biologic products. We focus on helping clients identify product specific quality attributes and deliver high quality data packages internal and external decision makers to enable successful regulatory filings.
Controlling and communicating measurement uncertainty in results is critical to mitigating risks throughout the process. From early phase research through to establishing lot release specifications for safety, purity, strength, identity and potency, unexpected findings must be investigated. Assay design, development and validation studies are integral to understanding the critical quality attributes of a product and statistics guide the generation, analysis and review of scientific data to support regulatory filings.
Areas of Expertise
- Potency assay design, development and validation
- Development and justification of phase appropriate lot release specifications
- Chemistry, Manufacturing and Control (CMC) support
- Regulatory submission review
- Responses to FDA queries
- Audit and evaluation of supporting data and documentation
- Investigations into product quality and assay issues
- Out of specification results
- Unexpected outcomes in preclinical or clinical studies
- QC controls trending