Marshall Biopharm Associates, LLC is a consulting firm committed to helping clients with their complete Manufacturing & Quality needs. With over 30 years experience In Process Development, Clinical and Commercial Manufacture of Biologics, Drugs, Devices and Combination Products in Devices, MBA LLC can help companies navigate through their Clinical Manufacturing journey to Commercialization, and has experience with over 30 Biologic, Peptide and Drug products. Services provided: * CMC pathway decision support * CMO selection services and contract negotiation support * Contract management of existing supplier network * Operations Strategic Planning, Long-Range Planning * Make vs. Buy C-Suite decision support * Financial analyses, COGS, C-Suite decision support tools * M&A support * Site/Facility acquisition, expansion/modification, start-up, financial planning * Technical troubleshooting and advanced problem solving * MBA has experience in Drug Substance, Drug Product, and Combination Products in various devices. * Access to associates with specific expertise in Quality, Validation, Regulatory Affairs, Manufacturing & Development support Products Manufactured, Captive or Contracted, Clinically and/or Commercially : Advate®, Amevive®, Bydureon®, Bydureon BCise®, Cinvanti®, Coseal®, Enbrel®, Erbitux®, Floseal®, Myalept®, Neisvac-C®, NPlate®, Prolia®, Recombinate®, Sensipar/Mimpara®, Sustol®, Symlin®, Vectibix®, Wellferon® Marshall Biopharm Associates, LLC NH Lic# 768680