We’re dedicated to excellence in research & development, manufacturing, in-depth testing, efficient packaging, and personalized service. We are committed to improving existing products and adding new products. We can assist your company in expanding your product line as well.
Our chemists routinely conduct stability testing on a variety of products stored under controlled temperature and humidity conditions in our validated stability chambers. Our real time and accelerated stability studies are conducted per ICH guidelines in order to establish the shelf-life of a product. In addition, we regularly conduct studies on products found on the market to monitor the stability of the product throughout it's shelf-life.
Serialization is described as the assigning of unique identifying numbers to each saleable unit of a prescription product. This identification number is linked to the products manufacturing location, batch lot number, and expiration date which helps provide traceability throughout the supply chain. Dental Technologies, Inc. is here to help your brand comply with Drug Supply Chain Securities Act (DSCSA) requirements.
Our Quality Assurance inspectors are responsible for inspecting all areas of production from material compounding to packaging. Our Quality Assurance team takes great care to ensure all components and labeling meet the required specifications.
Regulatory Affairs is an essential part of our business. Dental Technologies, Inc. is an FDA registered drug and medical device manufacturer, and also holds ISO 13485 certification with CE marking. We focuses heavily on making safe and effective dental products available worldwide. Our team has designed an outstanding Quality Management System with a strong focus on manufacturing controls. Our technical files contain all appropriate clinical evaluations and biocompatibility studies. All aspects of production including material testing, bulk manufacturing, filling, labeling, and packaging are documented and records are retained.
Our Quality Control Chemists continuously monitor your products. This process begins with incoming inspection of raw materials where we test to confirm identity, strength, quality and purity before ingredients are released for use in manufacturing. During manufacturing, chemists test bulk in-process samples and filled products using a variety of validated analytical methods to generate a certificate of analysis. Every product is subject to rigorous, well-documented testing procedures to ensure high quality standards.
Our chemists are supported by a sophisticated array of analytical equipment enabling them to perform:
• Color Spectrophotometry
• High-Performance Liquid Chromotography
• Gas Chromotography
• FTIR Spectrometry
• Mechanical Properties Testing
• Classic Wet Chemistry
From chromatographic separations to chemical techniques, all of our sampling, analytical and testing procedures are conducted according to FDA, ISO, and ADA approved methods.
Depend on Dental Technologies, Inc. to handle flexible manufacturing for everything from short runs to full-scale, continuous production. We have the capability to handle your largest runs, yet we are flexible enough to attend to every minute detail.
Our in-house packaging and design department has the experience to assist you throughout your packaging design process. From jars to tubes, we can design the most innovative package to match your exact needs
Our completely equipped in-house Microbiological Laboratory has fully developed Microbial Control Testing Programs to ensure the quality and shelf life of your products. Several functions performed by our Micro Lab include:
• Water Testing
• Sanitation Procedures
• Environmental Monitoring
• Detection and Identification of Micro-Organisms
• Swab Test Monitoring of Equipment
• Incoming Raw Materials Testing
• Finished Goods Testing
• Stability Testing
Dental Technologies, Inc. at the leading edge of product development for the professional oral-care industry. Our chemists have an extensive range of ability to bring your concepts and ideas into reality, modify or improve your existing product, and to work together with your development team on joint products. Our development team strives to uncover novel approaches to innovative products. Our abilities are proven by our successful development of over 500 formulas. Working with the understanding of market requirements, we utilize a team approach to meet the ever-changing demands and deadlines.