QIS, Inc. helps companies meet the standards set by the FDA. QIS, Inc. provides a full spectrum of services to assist drug companies gain a state-of-control in their quality and compliance systems to meet regulations at any stage of the drug substance or drug product lifecycle.
Well-defined written procedures that are understandable and can withstand the scrutiny of an inspection is crucial to a smoothly operating quality management system. QIS has perfected this art of technical regulatory writing. We create and optimize procedures that employees will value and appreciate and meet cGXP compliance requirements. QIS can examine the firms’ unique internal documents and processes to identify pathways to increase quality compliance, streamline efficiency and sustainability to meet cGXP regulations. Our capabilities include development of adequate controls and validation programs for equipment and production environments, and generation of compliant systems to maintain accurate and consistent data results in the laboratory. We can also facilitate plans to correct quality problems or assist with responses and commitments in FD-483’s or Warning Letters.
We provide regulatory technical writing services to transition investigational new drug (IND) or New Drug Application (NDA) submissions from paper to electronic format or generate submissions using a software platform with pre-designed templates in eCTD format to eliminate costly resubmissions.
Our services prepare companies to host FDA Inspections with confidence through customized role-play audits that provides employees an opportunity to practice and train for real inspections. QIS teaches the best practices and etiquette for interacting with FDA investigators during audits, how to set-up document staging areas and inspection process flows resulting in a stumble-free event for the company. We offer numerous other customized training sessions upon request.
FDA-regulated life science companies that have utilized our services range from prescription to OTC to Homeopathic industries. A sampling of products vary from Class II narcotic drug substances, sterile drugs product made by asceptic processing, lyophilized peptides, oral solid dosage tablets, oral solutions, medicated shampoos and dermatological prescription topical drug product creams.
Please view our Capabilities Overview for a detailed listing of areas where we may be of service to your company.