If you visit a doctor and receive a diagnosis stating that you require major surgery, would you just accept that and get on with the procedure? Or, would you seek a second opinion before going under the knife?
Second opinions can be just as important in the regulatory area of the life sciences industry. We recently had a client come to us with a question. They were planning to make a change in their drug’s formulation and were being told by their internal regulatory staff that this change would require them to perform human studies. They wanted to know if this was really necessary. We asked them some clarifying questions (how soluble is the drug? how well is it absorbed in the gut? what is the exact nature of the formulation change?) and were able to point them to specific pages in FDA guidance showing that only a comparative dissolution study would be needed. The savings in terms of money and time for the client were significant.
What does this mean in general? If you are not sure about the regulatory path forward for your project, whether it is a drug or device, working with Pearl Pathways just might save you from investing in expensive studies to obtain data that are simply not needed for regulatory approval. At Pearl Pathways we have experts with years of experience working with regulators for drugs and devices. Contact us to ask your question.