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European Medical Manufacturing Suppliers Directory Index
Regulatory Specialists Inc.
3722 Avenue Sausalito
Irvine, CA 92606 USA
Tel: +1 949 262 0411
Fax: +1 949 552 2821
E-mail: mail@regulatoryspecialists.com
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Description:
Provides regulatory affairs services to the medical device, diagnostics, and pharmaceutical industries. The company can handle all procedures necessary for filing for and obtaining 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 European Medical Manufacturing Suppliers Directory:
- Consultants: Auditing/Inspections (73 companies)
- Consultants: Clinical research (34 companies)
- Consultants: Clinical trials management (45 companies)
- Consultants: Conformity assessment (49 companies)
- Consultants: Product certification (46 companies)
- Consultants: Quality assurance/Quality systems (118 companies)
- Consultants: Registration/Submission assistance (61 companies)
- Consultants: Regulatory (113 companies)
- Consultants: Technical documentation (85 companies)
