Medical Device Qualified Supplier Directory
Regulatory Specialists, Inc Company Profile
Markets Supplied: North America, Europe
Contact: Robyn ScopisYear Established: 1989No. of Employees: 30
Regulatory Specialists Inc. provides regulatory affairs services to the medical device, diagnostic, and pharmaceutical industries. The company can handle all procedures needed to file for and obtain approval to market in the United States and abroad. Its expertise encompasses clinical studies, 510(k) premarket notification submissions, PMAs, IDEs, INDs, ANDAs, and NDAs, along with compliance issues pertaining to QSRs, ISO 13485, and the CE mark.