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Furthermore, we specialize in the development and validation of microbial assays tailored specifically for antibiotics, vitamins, drug substances, and drug products.
Our Method Development and Validation Services ensure that your microbiological testing protocols align with regulatory requirements, such as USP and EP standards. By providing validated methods, we help you achieve compliance and meet the necessary guidelines for non-sterile and sterile product testing.
With our expertise in method development and validation, we ensure accurate and reliable results for microbial enumeration, detection of specified microorganisms, sterility tests, and endotoxin testing. By using validated methods, you can have confidence in the accuracy and integrity of your microbiological testing data.
Validated microbiological methods are crucial for assessing product quality and safety. By detecting and quantifying microorganisms, characterizing their attributes, and assessing antimicrobial effectiveness, we help you ensure that your products meet the required microbial quality standards, minimizing the risk of contamination or compromised efficacy.
At Neopharm, we provide non-sterile validation services, including microbial enumeration, microbial characterization, detection of specific microorganisms, and Antimicrobial Effectiveness Testing. Our services comply with the guidelines set by USP<61> &<62> and EP 2.6.12 & 2.6.13 to guarantee the safety and effectiveness of your products for consumers. Our team of experts is committed to delivering the best quality results.
Our validation services for sterile products and devices ensure that your products are safe and effective. We provide Sterility Tests and Bacterial Endotoxins Tests that comply with various pharmacopeias and official methods. Our team of experts ensures optimal results every time. We also offer validation of Sterility Tests (USP <71>, EP 2.6.1) to confirm that products are free from viable microorganisms, as well as Bacterial Endotoxins Tests (USP <85>, EP 2.6.14) to detect or quantify endotoxins from Gram-negative bacteria.
Method development and validation in microbiology involves the design, optimization, and validation of testing methods to ensure accurate and reliable results for microbial enumeration, detection of specified microorganisms, sterility testing, and endotoxin testing. It ensures that the methods used for microbiological analysis are scientifically sound and meet regulatory requirements.
Method validation is crucial in microbiological testing as it establishes the reliability, accuracy, and performance of the testing methods. It ensures that the methods are suitable for their intended use, produce consistent results, and comply with regulatory standards, providing confidence in the accuracy of microbial data.
Method validation ensures that the microbiological testing methods used accurately assess the quality and safety of products. By validating methods for microbial enumeration, detection of specified microorganisms, sterility testing, and endotoxin testing, it helps identify potential contamination issues, ensure product efficacy, and protect patient safety.
Yes, at Neopharm, we have expertise in validating methods using various pharmacopeias or official methods. Whether it's USP, EP, or other recognized standards, we can tailor our validation services to meet your specific requirements and ensure compliance with the applicable guidelines.
Ensure accurate and reliable microbiological testing with Neopharm's Method Development and Validation Services in Microbiology. Our experienced team will develop and validate methods for microbial enumeration, characterization, detection of specified microorganisms, sterility testing, endotoxin testing, and more. Contact us today to discuss your specific needs and partner with us to ensure the quality, safety, and compliance of your products.Contact us