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xFDA • Marilyn A. Apfel • 9418 Columbia Blvd. • Silver Spring, Maryland 20910 • 301-495-2720 • XFDA experts can help you through the entire drug and device approval process. Experts all formerly involved with drug or device approval at the FDA Contact us for regulatory information.
Radiation Safety Academy • Greg Johnson • 481 N. Frederick Ave., Ste. 302 • Gaithersburg, Maryland 20877-2417 • 800-871-7930 • 301-990-9878 • For those who want the best understanding and assurance of radiation safety
Malcolm Pirnie, Inc. • Mark McGowan, CSP, CIH • 104 Corporate Park Drive • White Plains, New York 10602-0751 • 914 641-2484 • 914 641-2802
Sdli • Scott Wohlstein • P.O. Box 1190 • Franklin, Pennsylvania 16323-1190 • 814-437-7354 Excellent source for regulatory information.
Promedica International • Roy Freeman • 3100 Bristol St., Suite 250 • Costa Mesa, California 92626 • 714-799-1617 x 46 • 714-799-1680
Creative Essences • Elvie Daliva • 2228 E. Gladwick St. • Rancho Dominguez, California 90220 • 310-638-9277
Praxiom Research Group Limited • Ron Krebs • 9619 - 100A Street • Edmonton, Alberta T5K 0V7, Canada • (780) 461-4514 • (780) 463-6034
CL Tech. Inc. • Cezar Lucki • 13 Lassen • Irvine, California 92612 • 949-929-8254 • 413-581-3998
RegScan, Inc. • Sales Department • 800 West Fourth St. • Williamsport, Pennsylvania 17701 • 570.323.1010 x 1415 • 570.323.8082 • Regulations - Federal State, International; Change Management
Cleanroom Consulting, LLC • Scott E. Mackler • 31 Mitchell Road • Pittsford, New York 14534-2301 • 585-264-9430 • 585-264-9522 • Cleanroom design and applications, cGMP cleanroom compliance, contamination control consultation and troubleshooting.
R.A.Q.A. Associates, Inc. • David Bulman • 14 Willow Road • Queensbury, New York 12804 • 518/793-5545 • 518/793-5545 • R.A.Q.A. provides a full range of FDA regulatory and compliance consulting services to assist pharmaceutical and medical device clients.
Chris Flahive Associates • Chris Flahive • P.O. Box 63 • Belle Mead, New Jersey 08502 • 908-281-7000 • 908-281-7245 • Consulting to the medical device industry in the assessment, design, development, and implementation of FDA & international quality management systems
Quality Management Associates (SC), Inc. • Sereta Muse • P.O. Box 2907 • Irmo, South Carolina 29063 • 803-749-2667 • QMA (SC) provides a full range of FDA regulatory and compliance consulting services to assist biologics and medical device clients.
New World Regulatory Solutions, Inc. • Maureen Garner • P.O. Box 5374 • Toms River, New Jersey 08754 • 732-929-4803 • 732-270-4829
Dragon Hygiene Consultants • David Ronan • 105 Llwydarth Road • Maesteg, Mid Glamorgan South Wales CF34 9EU, Great Britain • 01656 737355 / 07903227168 • 01656 732610 • We carry out training & auditing to company,s in the UK & Europe this includes health & safety,risk assesments,fire risk assesments,vdu and hygiene.
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