Our robust regulatory affairs team is available to support your growth into new domestic and international markets. We can also provide assistance with a marketing regulatory strategy that is compliant with industry standards. Our experienced staff has the resources to assist you with:
- Personal care (cosmetic and OTC) regulatory support
- Dietary supplement regulatory support
- International regulatory and label law compliance
- Health Canada (QARs, Site Licenses, PIAFs)
- Certificates of Free Sale
- Certificates of Origin
- Domestic and International Protein Certificates of Export
- EU regulation support
- Halal certifications
- Organic certifications
- Kosher certifications
- Aloe (IASC) certifications
Our Quality Department is involved in all aspects of our business at Protec Laboratories. You will find it as part of product development, incoming inspections, documentation – every step from conceptualization to the final review and release of all our finished products.
The Quality Department has a combined experience of over 125 years, including degreed scientists in executive leadership roles. The Quality Management System at ProTec Laboratories is a comprehensive quality program designed to meet and exceed the cGMP requirements set forth in Title 21 of the CFR for parts 211, 110 and 111.
At ProTec , our facilities are designed to enable the proper flow of incoming materials and outgoing finished products. Whether raw materials or packaging are supplied by our customers or purchased by ProTec, all incoming materials receive the same attention. All materials must be vigorously inspected, approved and released by our Quality Department before they are moved into our warehouse. Every incoming material (raw material, packaging, labeling, etc) and finished product is assigned a unique control number. This ProTec lot number control system gives us the ability to ensure each item we use can be traced back to its origin.
An integral part of our comprehensive quality management system is our in-house quality control testing laboratory. It is here that the quality oversight of all raw and bulk in-process material occurs. The evaluation of these items by our quality team ensures that our finished products exceed your expectations. Our quality team reviews and identifies all raw materials against quality specifications prior to use to ensure only the best materials are used for your products. Raw material testing can range from identity testing using our FTIR spectrometer, to organoleptic analysis, to our own robust certificate of analysis verification program.
Total Quality System
ProTec Laboratory has earned the trust and confidence of our customers by demonstrating an unwavering commitment to superior quality. There is a viable sense of pride and care that is put into our work that sets us apart from most nutritional contract manufactures. A quest for quality coupled with an attention to detail that is part of everything that we do.
We have built a reputation for excellence by assisting our customers in their effort to stay at the forefront of new and impending regulations in the dietary supplement industry. You can trust us to know the not only what the current regulations are but also where the future is going.
We want to give our partners the opportunity to take a long view approach to their business and brands and have a partner they can trust to deliver the highest quality products for their consumers that allow for them to live their best life.
Our Quality Control Procedures meet or exceed current Good Manufacturing Practices (cGMP). Meet or exceed all regulations set forth by the FDA and are fully certified by NSF.