Service by Regulation Code

Service by Regulation Code

Protheragen-ING Lab understands that regulatory compliance is essential for businesses to operate legally and maintain consumer trust. With state-of-the-art facilities and advanced testing methodologies, we offer comprehensive customized testing services that comply with regulatory norms and standards to ensure your adherence to these specific regulatory requirements, giving you peace of mind and minimizing potential risks. Our commitment to excellence, in-depth expertise, and tailored solutions make us the ideal choice for companies seeking reliable compliance support.

Tailored compliance solutions

Protheragen-ING Lab recognizes that each industry and product may be subject to different regulatory requirements. Our extensive expertise and experience with a wide range of regulatory requirements allow us to customize our services to your unique compliance needs. Below are specific examples of the testing services we can provide.

Fig.1 Service by Regulation Code

  • California's Prop 65 Testing
    As per California's Proposition 65, businesses are required to provide warnings for products that contain chemicals known to the state to cause cancer, birth defects, or other reproductive harm.
    Our laboratories offer a full range of testing services to help determine whether products contain any of the listed chemicals and to assess their exposure levels. We can guide you through the complex Proposition 65 compliance process to ensure that your products meet the necessary regulatory standards.
  • 40 CFR Part 158 Testing
    The U.S. EPA regulates the registration and use of pesticides under 40 CFR Part 158.
    Our testing services assist pesticide manufacturers and registrants in evaluating the efficacy, safety, and environmental impact of their products. We conduct a wide range of studies, including acute toxicity testing, residue analysis, ecotoxicology, and environmental fate assessments.
  • 21 CFR Part 610 Testing
    Under 21 CFR Part 610, the FDA sets forth regulations for the testing and control of biological products. Our laboratory provides comprehensive testing services to ensure compliance with these regulations, including sterility testing, potency assays, endotoxin testing, and stability studies.

Protheragen-ING Lab's testing capabilities

  • Chemical Analysis: We identify and quantify a wide range of substances, including heavy metals, organic compounds, pesticides, and other contaminants in accordance with regulatory codes. Our laboratories are equipped with cutting-edge analytical instruments such as gas chromatography (GC), liquid chromatography (LC), mass spectrometry (MS), atomic absorption spectrometry (AAS), and inductively coupled plasma (ICP) technology.
  • Toxicity Testing: We offer a wide range of toxicity testing including acute toxicity, chronic toxicity, genotoxicity, and ecotoxicity assessments.
  • Microbiological Testing: Our capabilities include microbial identification, microbial enumeration, sterility testing, and endotoxin testing.
  • Residue Analysis: We use advanced techniques such as High-Performance Liquid Chromatography (HPLC), GC-MS, and LC-MS/MS to accurately detect and quantify trace residues to determine the presence or absence of pesticides, veterinary drugs, and other chemical residues in food, agricultural, and environmental samples.
  • Stability Studies: We conduct stability studies by relevant regulatory guidelines to evaluate the shelf life and performance of pharmaceutical, biotechnology, and other products under a variety of environmental conditions.

Fig.2 Protheragen-ING Lab's chemical analysis capabilities

Contact us today to discuss your specific regulatory compliance needs and learn how our services can help you achieve and maintain compliance with confidence.