Regulations Suppliers (North America)

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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. - Quality supplier of regulations.

New World Regulatory Solutions, Inc. • Maureen Garner • P.O. Box 5374 • Toms River, New Jersey 08754 • 732-929-4803 • 732-270-4829

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.

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 • Quality, environmental, information security, food safety, and occupational health and safety management standards translated into plain English. - Call us when you need regulations.

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

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

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.

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. - Excellent source for regulations.

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

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.

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

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 - Contact us for regulations.

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

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.

CyberRegs • Cyberregs • 5111 N. Scottsdale Rd. #200 • Scottsdale, Arizona 85250 • 8008083372 • Dynamic regulatory document library containing environmental health and safety regulations

Sdli • Scott Wohlstein • P.O. Box 1190 • Franklin, Pennsylvania 16323-1190 • 814-437-7354

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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