Professional engineer specializing in transport validation for biologics/pharmaceuticals. My transport validation programs have been included in eight successful commercial approvals for Biologics in the US and in Europe. My regulatory approval record also includes small molecules, capsules and tablets, and drug/device combinations.
As Engineering Manager at Modality Solutions, I provide the staffing, strategic leadership, and technical guidance to all of our consulting projects. My team specializes in working with commercial filings for Biologics, including CGT, ADCs, and drug-device combinations. Our experience includes validation programs for biologics licensed by companies such as Incyte, Immunogen, and Amicus, as well as cell therapy programs by Vertex, Atara, and Adaptimmune.
The engineering team at Modality Solutions is your go-to for transport validation for commercial filings. Feel free to reach out to discuss pharmaceutical supply chain validation.