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Emergo Group Medical Device Consultants • Chris Schorre • 611 West 5th Street, Third Floor • Austin, Texas 78701 • 1-512-327-9997 • 1-512-327-9998 • Emergo Group provides international quality and regulatory consulting services to medical device companies worldwide. - Contact us for regulatory information.
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
fda drug and medical devices consulting • Marilyn A. Apfel • 9418 Columbia Blvd. • Silver Spring, Maryland 20910 • 301-495-2720 • XFDA consulting is a group of FDA medical device and drug development consultants providing preclinical, clinical, CMC and regulatory consultation to
Creative Essences • Alpha Mendoza • 2228 E. Gladwick St. • Rancho Dominguez, California 90220 • 310-638-9277 - Quality supplier of regulatory information.
RegScan, Inc. • Sales Department • 800 West Fourth St., Suite 202 • Williamsport, Pennsylvania 17701 • 570.323.1010 x 1415 • 570.323.8082 • Regulations - Federal State, International; Change Management
Clinstep LLC - Regulatory Affairs Consultancy • Lan-Anh Chung, M.Sc. • 375 N Stephanie St, Suite 1411 • Henderson, Nevada 89014 • 702-994-0316 • 702-405-7802 • A regulatory affairs consulting company, that provides various services to the medical device and pharmaceutical industry.
Malcolm Pirnie, Inc. • Mark McGowan, CSP, CIH • 104 Corporate Park Drive • White Plains, New York 10602-0751 • 914 641-2484 • 914 641-2802 • Malcolm Pirnie, a century-old environmental consulting firm, provides comprehensive services in water and wastewater engineering, solid and hazardous
Promedica International • Roy Freeman • 3100 Bristol St., Suite 250 • Costa Mesa, California 92626 • 714-799-1617 x 46 • 714-799-1680 • A contract research organization that assists medical product manufacturers with the management of clinical studies, FDA registrations, and FDA compli - Call us when you need regulatory information
Praxiom Research Group Limited • Ron Krebs • 9619 - 100A Street • Edmonton, Alberta T5K 0V7, Canada • (780) 461-4514 • (780) 463-6034 • Quality, environmental, information security, food safety, and occupational health and safety management standards translated into plain English.
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.
International Molded Fiber Association • Cassandra Niesing • 1425 W. Mequon Rd. • Mequon, Wisconsin 53092 • 262-241-0522 • 262-241-3766
CyberRegs • Sales • 5111 N. Scottsdale Rd. #200 • Scottsdale, Arizona 85250 • 8008083372 • Dynamic regulatory document library containing environmental health and safety regulations - Excellent source for regulatory information.
Cleanroom Consulting, LLC • Scott E. Mackler • 12123 Edgestone Road • Dallas, Texas 75230-2341 • 214-484-8502 • 214-484-9305 • Cleanroom design and applications, cGMP cleanroom compliance, contamination control consultation and troubleshooting.
CL Tech. Inc. • Cezar Lucki • Irvine, California 92612 • 949-929-8254 • 866-255-0580 • Compliance, quality engineering, and validation services per EMEA / FDA regulation and ISO / GAMP standards.
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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