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Regulatory Information Suppliers


fda drug and medical devices consulting www.xfda.com • Marilyn A. Apfel • 9418 Columbia Blvd. • Silver Spring, Maryland 20910, USA • 301-495-2720 • XFDA consulting is a group of FDA medical device and drug development consultants providing preclinical, clinical, CMC and regulatory consultation to - Excellent source for regulatory information.

Promedica International www.promedica-intl.com • Roy Freeman • 3100 Bristol St., Suite 250 • Costa Mesa, California 92626, USA • 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

Quality Management Associates (SC), Inc. • Sereta Muse • P.O. Box 2907 • Irmo, South Carolina 29063, USA • 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 www.imfa.org • Cassandra Niesing • 1425 W. Mequon Rd. • Mequon, Wisconsin 53092, USA • 262-241-0522 • 262-241-3766

Sdli www.kwkid.com/SDLI • Scott Wohlstein • P.O. Box 1190 • Franklin, Pennsylvania 16323-1190, USA • 814-437-7354 - Contact us for regulatory information.

Chris Flahive Associates • Chris Flahive • P.O. Box 63 • Belle Mead, New Jersey 08502, USA • 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

Radiation Safety Academy www.radiationsafetyacademy.com/ • Greg Johnson • 481 N. Frederick Ave., Ste. 302 • Gaithersburg, Maryland 20877-2417, USA • 800-871-7930 • 301-990-9878 • For those who want the best understanding and assurance of radiation safety

Clinstep LLC - Regulatory Affairs Consultancy www.clinstep.com • Lan-Anh Chung, M.Sc. • 375 N. Stephanie St, Suite 1411 • Henderson, Nevada 89014, USA • 702-994-0316 • 702-405-7802 • A regulatory affairs consulting company, that provides various services to the medical device and pharmaceutical industry.

Instantel www.instantel.com • Ron Mask • 309 Legget Drive • Kanata, Ontario K2K 3A3, Canada • 18002679111 - Quality supplier of regulatory information.

R.A.Q.A. Associates, Inc. www.raqaassociates.com • David Bulman • 54 Meldon Circle • Queensbury, New York 12804, USA • 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.

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

Malcolm Pirnie, Inc. www.pirnie.com • Mark McGowan, CSP, CIH • 104 Corporate Park Drive • White Plains, New York 10602-0751, USA • 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

Praxiom Research Group Limited www.praxiom.com/ • 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 regulatory information.

CL Tech. Inc. qualityleader.com • Cezar Lucki • , • Irvine, California 92612, USA • 949-929-8254 • 866-255-0580 • Compliance, quality engineering, and validation services per EMEA / FDA regulation and ISO / GAMP standards.

Cleanroom Consulting, LLC www.cleanroom-consulting.com • Scott E. Mackler • 12123 Edgestone Road • Dallas, Texas 75230-2341, USA • 315-382-3440 • Cleanroom design and applications, cGMP cleanroom compliance, contamination control consultation and troubleshooting.

Emergo Group Medical Device Consultants www.emergogroup.com • Chris Schorre • 816 Congress Avenue, Suite 1400 • Austin, Texas 78701, USA • 1-512-327-9997 • 1-512-327-9998 • Emergo Group provides international quality and regulatory consulting services to medical device companies worldwide.

RegScan, Inc. www.regscan.com • Sales Department • 800 West Fourth St., Suite 202 • Williamsport, Pennsylvania 17701, USA • 570.323.1010 x 1415 • 570.323.8082 • Regulations - Federal State, International; Change Management

CyberRegs www.cyberregs.com • Sales • 5111 N. Scottsdale Rd. #200 • Scottsdale, Arizona 85250, USA • 8008083372 • Dynamic regulatory document library containing environmental health and safety regulations

Dragon Hygiene Consultants www.dragonhygiene.co.uk • 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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