As a global developer, manufacturer, and supplier of pharmaceutical products, NovaCina has expertise in all facets of pharmaceutical operations that can be tailored to either supplement, review or manage your needs to meet the Regulatory requirements of all key markets.
- Preparing Regulatory Audit responses – root cause analysis and corrective and preventative action determination and implementation
- Pharmaceutical engineering – process design and validation for aseptic and terminally sterilized product manufacturing processes
- Sterilization expertise – autoclave load development and validation, and inline steam sterilization validation
- Media fill management – media fill program design, protocol preparation and assessment
- Aseptic subject matter experts who can provide technical support and compliant practical solutions to your requirements
- Quality by design – Quality Manual and SOP preparation
- Compliance investigation and response analysis – root cause analysis and corrective and preventative action determination and implementation
- Risk management and mitigation – design and preparation of Risk Assessments and Risk Management Plans
- Packaging & labeling – visual inspection and product sterilization process development and validation
- Storage & distribution – cold chain distribution logistics and validation
- Training on all technical and practical applications of Root Cause analysis, Lean Manufacturing Principles, Human Error Reduction and Data Integrity in Pharmaceutical manufacturing