Starsiak Consulting provides professional quality assurance contract services based on the pharmaceutical or medical device client's specific business needs. A summary of key services is listed below.
We have the comprehensive experience necessary to develop customized quality system SOPs and data collection forms to fit your business culture and to comply with FDA cGMP requirements for pharmaceutical manufacturers, warehouses, laboratories and service providers. We provide a system of document management for version control of your SOPs.
We have the knowledge and regulatory understanding to assess your contract manufacturers, component suppliers, API manufacturers, packaging/labeling vendors, warehouses, laboratories, and service providers to ensure compliance to FDA cGMP regulations. We also support due diligence audits and can conduct your internal functional area QA audits. We have experience to conduct an intensive mock PAI or gap analysis in preparation for your upcoming FDA inspection or product launch.
We can support your QA functional needs including clinical or commercial batch record review, complaint management, manufacturing line oversight, person in the plant, validation, product investigations, and documentation management. We can provide support to your specific area of need or provide full service QA coverage.
Services are available for all areas of pharmaceutical QA support.
Please contact us to discuss your specific QA consulting needs, and we can provide a detailed custom proposal to describe how we can effectively support your goals.