Our Goal and Yours are One – Regulatory Approval of your Therapy

We understand what it is like to be surrounded by regulations, obscure requirements and sometimes confusing communications. We know that your goal is to have the regulatory agencies license your product as quickly and efficiently as the demands for safety and efficacy allow. We want to work with you to help minimize the amount of non-clinical safety pharmacology, toxicology, pharmacokinetic, reproductive and genetic toxicology information you need to progress rapidly into the IND phase for your product. We want to try to anticipate any clinical toxicities to minimize unwanted surprises in Phase 1. We can help you correlate Phase 1 clinical results with non-clinical results to support your therapies safety and efficacy profile. We want to be there early in the vital End-of-Phase 2 meeting preparation so that you will know exactly what non-clinical studies you will need to do concurrently during Phase 3 clinical development and we want to minimize those requirements where possible. Lastly, we want to help ensure that your NDA package is complete, thorough and SEND compliant so that you can provide your submission to the regulatory agencies with confidence.

 
We have over 23 years of direct experience working within the US Food and Drug Administration. While there, our combined portfolios included over 430 Investigational New Drug (IND) submissions and 40 New Drug Application (NDA) submissions with 18 approved new products and numerous approved supplemental indications (sNDA). We have helped write guidelines for the International Conference on Harmonization (ICH) of drug development and FDA guidance publications. We have been responsible for the human safety of drug therapies at all levels of clinical development, including protocol development, clinical monitoring and drug labeling. The products we have overseen include a variety of first in class small molecules, antibodies, antibody drug complexes, immunotherapies, therapeutic proteins and other biological compounds, hormonal therapies, nanoparticles, photodynamic therapy, and devices. Our services cover all phases of development from simple Investigators Brochure review to helping you put together your entire IND or NDA. We can help you develop your therapy efficiently and quickly. You want to improve human health and that is our goal as well. Please don’t hesitate to contact us to find out how we can help you achieve our mutual goal – approval.