Medical Device Qualified Supplier Directory

 

Regulatory Specialists, Inc Company Profile

 

www.regulatoryspecialists.com
E: [email protected]
T: 949/262-0411

Address
3722 Ave. Sausalito, Irvine, CA, 92606, United States
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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.

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www.regulatoryspecialists.com
E: [email protected]
T: 949/262-0411

Address
3722 Ave. Sausalito, Irvine, CA, 92606, United States
View map