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Regulatory Specialists Inc.
3722 Ave. Sausalito
Irvine, CA 92606
Tel: 949/262-0411
Contact: Greg Holland
Year Established: 1989
No. of Employees: 20
Web: http://www.regulatoryspecialists.com
E-mail: mail@regulatoryspecialists.com
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Description:
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.
Categories this company is listed under in the Consultants Directory on Medical Device Link:
- Clinical Research (19 companies)
- Europe: Marketplace/ Regulations (25 companies)
- Good Manufacturing Practices/Compliance (53 companies)
- ISO 9000 (21 companies)
- Process Validation (32 companies)
- Quality Assurance (47 companies)
- Regulatory Affairs (51 companies)
