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Phoenix Regulatory Associates Ltd.
21525 Ridgetop Cir., Ste. 240
Sterling, VA 20166
Tel: 703/406-0906
Fax: 703/406-9513
Contact: Dr. C. K. Gund, Dr. Clyde Takeguchi
Year Established: 1991
Web: http://www.phoenixrising.com
E-mail: phoenix@phoenixrising.com
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Description:
Phoenix Regulatory Associates offers expert technical and scientific regulatory affairs assistance. Its services including premarket submissions, QSR and data integrity audits, GMPs, ISO procedures, 483s and warning letter responses, process validation, good clinical practices and human subject protection compliance, quality assurance, importation matters, training, strategic planning, registration/listing, and U.S. agent duties for FDA requirements.
Categories this company is listed under in the Consultants Directory on Medical Device Link:
- Audits/Inspections (43 companies)
- Good Manufacturing Practices/Compliance (53 companies)
- Process Validation (32 companies)
- Quality Assurance (47 companies)
- Regulatory Affairs (51 companies)
- Training (33 companies)
