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Our experts will design and help manufacture your ELISA Assay.
We have successfully conducted R&D trials as well as prepared and submitted 510(k) applications for over one hundred medical devices that range from ELISA Assays for detecting IgG and IgM Antibodies in human serum to ELISA Kits for the Detection of Lyme Disease in Humans. We offer support for the trial and preperation of the entire submission package to the FDA. Our 510(K) services will result in streamlines and effective submissions with minimal questions during the FDA review process.
We have near 30 years experience in generation of data for FDA submissions and subsequent market clearance. Over one hundred submissions have been cleared by the FDA. We do design and conduct the clinical study protocols, monitoring and data analysis in addition to writing and interfacing with the FDA for clients. The technical knowledge and background of our immunology experts will ensure timely and economical data generation and submission with subsequent 510(K) approval. Subsequently, we will train your GMP production facility on manufacturing of the recently 510(K) cleared products to ensure your new products are manufactured to the claimed specifications and highest quality every single time.
Clinical trials: Designed clinical trial plan that reduced the number of sites, number of patients, and facilitated the validation and analysis of collected data. Significant savings realized in schedule and cost.
In short, you will hire us to add a complete FDA cleared product from scatch in the shortest time, with the least possible number of clinical trial sites and resources. In the end, you will have added many FDA cleared products to your offerings that your competition will envy you.
Please contact us and let us serve your 510(K) needs.
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