As new technologies and therapies emerge, ATMPs are becoming increasingly important. Applying for and writing an ATMP can be a difficult business as they are more complicated than a standard RMP. You really need to have experience in writing them to know what additional concerns need to be addressed. For example, for a gene therapy ATMP you would need to know about viral loads and viral shedding, and this will change depending on the product.
In addition, you will need to complete your environmental impact which you wouldn’t ordinarily need to undertake for another general product.
How can Essjay Solutions help?
We have extensive experience in writing ATMPs and ensuring that the risk concerns regarding these products are addressed appropriately. Contact us today to find out more.