Our Team

Founder and CEO of Ronald Marchesani Consulting, LLC. With over 48 years' experience in the Pharmaceutical, Biologics, Vaccines and Medical Device industries. Have held senior Quality executive positions in at Alvotech (Iceland), Samsung Biologics (South Korea), Onyx Pharmaceuticals/Amgen (CA, USA) and Shire Biologics/ID Biomedical (Canada). Have direct experience in working government contracts (DOD, CDC, Canadian DND and British MOD) on biodefense vaccines (example, 2n generation Smallpox vaccine) and strategic pharmaceutical stockpiles.
Since consulting from 2019, have held Executive Advisor positions with various Virtual and small to midsized Biotechnology companies and acted as interim head of Quality for various client companies. Have direct experience in hosting and interfacing with the following international regulatory organizations:
FDA, Health Canada, EMA, MHRA, MFDS, PMDA and TFDA.


Have conducted audits (100+) and mock Pre-Approval Inspections for various companies and clients.