IND Package Design and FDA Submission

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Center for Biomedical Testing senior personnel have more than 100 years of combined professional experience and are fully equipped to design and execute the entire IND package for your drug or device.

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We will support your drug development from the early efficacy proof of concept phase to IND submission and FDA agreement to start the clinical trial.

We will provide you with the most cost-effective and efficient path to clinical trials.

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Our specialists have been involved in the development of hundreds of different drugs and devices, including but not limited to cancer therapies for numerous indications, cancer prevention, thrombosis, infectious diseases (including vaccines), sepsis, acute respiratory syndrome, diabetes, Parkinson’s disease, radiation injury, hair growth, and many other small molecules and biologics.

 

Our experienced team is ready to prepare the Pharmacology, Toxicology, CMC and clinical protocol sections of the pre-IND and IND packages.

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In the last 5 years we have designed and executed 4 entire IND packages and these drugs are now in the clinical trials and we are currently working on another complete IND package.

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The most recent FDA agreement to start the clinical trial of a new imaging agent was received on April 9, 2020.

 

CBT also provides ongoing support for the clinical trials with validated analytical methods of plasma drug levels determination and pharmacokinetics support.