Michael Gross, Ph.D., RACPrincipal Consultant

Chimera Consulting North America LLC

Michael Gross, Ph.D., RAC is the Principal Consultant of Chimera Consulting. Michael has extensive experience in the development, registration, regulation and compliance for drugs, biologics, medical devices and combination products. He has worked in the medical products industry for over thirty years in senior quality and regulatory affairs roles and as a biologics reviewer and inspector at the FDA. He has worked for a number of large and small pharmaceutical and biotech companies and for a large medical device manufacturer. He has also held a senior compliance position in a large pharmaceutical company. He has hands-on experience in a variety of therapeutic areas including cardiovascular, neurological, pulmonary, urology, oncology, ophthalmology, dermatology, anti-infectives, orthopedics, endocrinology and blood products and generic drugs.

Michael has worked hands-on with a variety of drug delivery systems, infusion pumps, reconstitution systems, catheter flush solutions, surgical kits, medicated devices, computer controlled devices and drug/laser combinations for photodynamic therapy. He understands complex combination product development and regulatory issues. He is experienced in pre-clinical, clinical, pharmaceutics, quality, labeling, submissions and post-marketing compliance matters related to drugs, biologics, medical devices and combination products.

Michael has worked on the development and registration of pre-filled transdermal drug delivery technologies, including passive, active and microneedle patches. He is experienced with pre-filled drug injection devices such as syringes, auto-injectors, injection pens, cartridges, jet injectors, drug reconstitution systems, and nasal and pulmonary drug delivery devices. He also has experience with finished medical devices such as needles, syringes, catheters, catheter flush syringes, infusion pumps, computer controlled medical devices, and lasers, and medicated devices and surgical convenience kits which are combination products.

Michael has personally written or managed submissions of investigational exemption applications [IND, IDE], drug applications [505(b)(1) NDA, 505(b)(2) NDA, sNDA, ANDA, BLA], device applications [510(k), PMA] and other FDA regulatory filings [RFD, DMF, BMF, MAF] in conventional and CTD/eCTD formats. Michael has also written and submitted regulatory filings to European Health Authorities.

Michael plays an influential role providing an industrial perspective on the regulation of combination products. He has presented testimony at FDA hearings (click here to view presentation) and is a frequent speaker at industry meetings on combination products and drug delivery systems. Between 1998 and 2012 he served as the Leader of the PDA’s Combination Product Interest Group and from 2008 to 2012 he served as co-chair of PDA’s Combination Products Task Force. He has authored numerous scientific and regulatory publications, many of which are on combination products. A summary of his Curriculum Vitae is provided here click to open.

technical, regulatory affairs, quality assurance, compliance consulting