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 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 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 facilitate plans to correct quality problems or assist with responses and commitments in FD-483’s or Warning Letters. We also provide regulatory review services and technical writing services for Investigational New Drug (IND) or New Drug Application (NDA) submissions.
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.
cGMP Quality SystemSupport
API & Finished Drug cGMPs
- Compliance & GAP Analysis auditing
- FDA Inspection Readiness planning
- FD-483 and Warning Letter support
- Document Control Systems
- Facility & Equipment Controls
- Material Handling & Warehouse Controls
- Production & Process Controls
- CAPA investigation support
- Post-Market Complaint handling
- Validation support
- Aseptic Sterile manufacturing support
- Water Systems support
- Stability Programs support
- Analytical Method Validation or Transfer support
- Auditing, Writing, Editing,Optimization of Lab procedures
- Calibration & Preventive Maintenance Program
- Laboratory OOS Investigation Assistance
- Equipment & Instrument Qualification support
- QC Data & Record Reviews
- Sample Handling Controls
- Contract Lab Supplier Qualification support
- Response writing
- Review Data in IND & NDA submissions
- Assistance with compiling submissions
- API & Drug characterization assistance