Our Team

Partners and Collaborators

The Gnomon Group

Regulatory

The Gnomon Group is a network of 15 regulatory consultants with over 200 years of combined pharmaceutical development experience in large and small companies, CROS, and as consultants. They have provided regulatory support for over 150 Investigative New Drug (IND) applications, including 15 compounds from early development to approved New Drug Application (NDA). Their expertise spans chemistry, manufacturing and controls (CMC), good manufacturing/laboratory/clinical practices (GMP, GLP, GCP), biostatistics, data management, medical writing, data safety medical board (DSMB) support), clinical operations, pharmacokinetics, pharmacology/toxicology, medical monitor and drug safety, esubmissions, and project management. The Gnomon Group has US and International regulatory experience across all phases of development for drugs, biologics, and medical devices.

Gilero

Medical Device Engineer

Gilero works with some of the most trusted brands in the world to design innovative medical devices, drug delivery systems, and combination products. Our medical device manufacturing services integrate years of design, engineering, and manufacturing expertise. With a proven capacity to innovate, scale and commercialize, Gilero’s domestic and international facilities are equipped to develop unique manufacturing solutions and accelerate device commercialization timelines. Gilero is FDA registered, ISO 13485 certified and compliant with cGMPs.
www.gilero.com

Fox Rothschild

Founded in Philadelphia over a century ago, Fox Rothschild is a national law firm with 950 attorneys in 29 offices serving clients in more than 70 practice areas, including Intellectual Property, Corporate, Labor and Employment, Litigation and Real Estate. The firm has been named among the “Most Feared Law Firms in Litigation” by BTI Consulting in each of the last seven years and more than 90 of its attorneys have been selected to the list of ranked attorneys in their disciplines by Chambers & Partners, considered the foremost source of legal industry research. Deeply committed to principles of diversity, equity and inclusion, Fox Rothschild has earned a perfect score on the Human Rights Campaign’s Corporate Equality Index for four consecutive years and was named a Top Performer and Compass Award Winner in 2021 and 2022 by the Leadership Council on Legal Diversity.