NAMSA offers technical consulting along with research method development capabilities. This unique combination of clinical advisory and validation services, coupled with fully equipped R&D laboratories, allow us to provide insight into testing issues and to become an extension of your company.
Two specific areas where we can provide extensive assistance in the medical device product development process are the research development and validation of analytical methods and the development and characterization of new sterilization processes.
Analytical Method Development and Validation
Before the analysis of leachables samples, a test method must be developed and validated to ensure that the analytes of interest are not obscured or affected by the formulation of the drug product. Our consultants and senior scientists will partner with you to determine the appropriate analytes of interest for testing. Drawing from resources available in literature, or performing extractables profiles in our chemistry laboratory, we will assist you in determining specific analytes of interest for your product. We then develop methods for these analytes in the presence of your drug product, ensuring that any samples preparation procedures are incorporated into these methods. Following development, the method is then validated per ICH guidelines.
The studies involved in NAMSA’s validation services include:
- linearity testing
- precision (repeatability and intermediate precision testing)
- limit of detection
- limit of quantification
- robustness and stability of test solutions
Our Research and Development Department has a proven track record with clinical research method developments and validation services using the following techniques with a multitude of drug product solutions:
- Gas chromatography (GC)
- Gas chromatography/mass spectroscopy (GC/MS)
- High-performance liquid chromatography (HPLC)
- High-performance liquid chromatography/mass spectroscopy (HPLC/MS)
- Inductively coupled plasma (ICP) spectroscopy
- Ultraviolet/visible (UV/VIS) spectroscopy
New Sterilization Process Development and Characterization
NAMSA’s consultants and senior scientists can also assist with the development and characterization of new sterilization processes. We offer consulting services on FDA’s requirements for the testing required for a 510(k) submission for a new sterilization process. We can install your sterilizer at our facility to perform the testing, or we can help you develop testing protocols for work to be done at your location. With the resources in our other internal disciplines at NAMSA, we can also assist in developing biological and chemical indicators, perform testing to prove that the sterilizer and sterilized materials are safe, and investigate the toxicity of any residuals. In addition, we can provide regulatory guidance on the 510(k) application, up to and including drafting the 510(k).