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Medical & Regulatory Writing Companies in the US

Medical & Scientific Writing

Medical & Regulatory Writing Companies in the US

Medical and regulatory writing in the United States for submission to the US Food and Drug Administration (FDA) requires a clear understanding of the requirements laid down by the regulatory agency. The documents to be submitted to FDA must be complete, clear, succinct and accurate.

Many pharmaceutical and biotechnology companies in the United States are often looking for medical and regulatory writing service providers to help them with their regulatory writing and compilation of dossiers for submission. Most often documents are submitted to the FDA for permission to conduct clinical trials (Investigational New Drug Application) and for marketing approval of new drugs (New Drug Application).

Following is a list of companies (service providers) in the United States that offer specialized medical and regulatory writing services:


Bioscript Regulatory
410 South 11th Street
Philadelphia
PA 19147 USA
T +1 (267) 239-2077


Cactus Medical
Three Neshaminy Interplex,
Suite 301, Trevose, PA 19053
Phone:+1-215-244-8100
Fax: +1-215-245-4705
Office hours: 0900 to 1700 Eastern


Caudex Medical
111 Eighth Avenue
Suite 723A
New York, New York 10011
United States
Tel: +1 212 462 7820
Fax: +1 212 462 7825


Allphase Clinical Research
33 Wood Avenue South
6th Floor
Iselin, New Jersey 08830
United States
732-744-3435(Tel)
732-744-3436 (Fax)


Advanced Clinical Research Services, LLC
1200 Lakeside Drive
Bannockburn, Illinois 60015
United States
(847) 267-1176 (Tel)
(847) 267-1432 (Fax)


Frontage Laboratories, Inc.
224 Valley Creek Blvd
Suite 300
Exton, Pennsylvania 19341
United States
1-610-232-0100
1-610-644-5426 (Fax)


Clinquest
One Cabot Road
Hudson, Massachusetts 01749
United States
978-568-8880
978-568-8206 (Fax)


Beckloff Associates
7400 W. 110th St.
Third Floor
Overland Park, Kansas 66210
United States
913-451-3955
913-451-3846 (Fax)


Integrium LIC
14351 Myford Road
Tustin, California 92780
United States
1 (714) 541-5591
1 (714) 541-5601 (Fax)


GRS
2101 Gaither Rd., Ste 450
Rockville, Maryland 20850
United States
301-424-9700


Research Point
1301 S. Mopac Expressway
Suite 50
Austin, Texas 78746
United States
512.343.1092
512.343.1684 (Fax)


Rho Services
6330 Quadrangle Dr.
Chapel Hill, North Carolina 27517
United States
919-408-8000
919-408-0999 (Fax)


Target Health Inc
261 Madison Avenue
New York, New York 10016
United States
212.681.2100


StatWorks, Inc.
79 T.W. Alexander Drive
Building 4401, Suite 240
Research Triangle Park, North Carolina 27709
United States
(919) 237-4300
(919) 237-4301 (Fax)


Trio clinical research
8045 Arco Corporate Dr
Suite 200
Raleigh, North Carolina 27617
United States
877.309.8746
919.403.7139 (Fax)


Datatrial Limited
3200 Beechleaf Court
Suite 409
Raleigh, North Carolina 27604
United States
(919) 277 0050
(919) 277 0033 (Fax)


Allied Research International (ARI)
4520 Dixie Road
Mississauga, Oregon L4W 1N2
United States
905-238-0599
905-238-0682 (Fax)


Amarex
20201 Century Blvd
Suite 450
Germantown, Maryland 20874
United States
301.528.7000


Pierrel Research USA
1275 Drummers Lane, Suite 100
Wayne, PA 19087
Phone +1 610 975 9533 or
+1 800 355 9533
Fax +1 610 975 9556


PAREXEL International
(Headquarters)
195 West Street
Waltham, MA 02451
Phone: +1 781 487 9900
Fax: +1 781 487 0525


PAREXEL International
Glendale Adventist Medical Center
1560 E. Chevy Chase Drive
Suite 140
Glendale, CA 91206
Phone: +1 818 254 1600
Fax: +1 818 545 7044


PAREXEL International
9920 Pacific Heights Blvd.
Suite 500, San Diego, CA 92121
Switchboard: +1 858 452 2345
Fax: +1 858 452 6543
SD Helpdesk: +1 858 795 6365


Quintiles, Global Headquarters,
Durham, North Carolina
4820 Emperor Blvd
Durham, NC 27703
Tel: +1 919 998 2000
Fax: +1 919 998 2003


Quintiles, Morrisville, North Carolina
5927 South Miami Boulevard
Berrington Building
Morrisville, NC 27560
Tel: +1 919 998 2888


Quintiles, Rockville, Maryland
1801 Rockville Pike
Suite 300
Rockville, MD 20852
Tel: +1 301 530 9222
Fax: +1 301 272 2150


Quintiles, San Diego, California
10201 Wateridge Circle
San Diego, CA 92121
Tel: +1 858 552 3400
Fax: +1 858 552 0611


Quintiles, Hawthorne, New York
8 Skyline Dr
Hawthorne, NY 10532


ICON Development Solutions
6031 University Boulevard
Suite 300, Baltimore
Ellicott City, MD 21043
US
Tel: +1 (410) 696 3000
Fax: +1 (410) 480 0776


ICON Clinical Research
Lake Forest
150 South Saunders Road
Suite 100
Lake Forest, Chicago, IL 60045
US
Tel: +1 (847) 235-5300
Fax: +1 (847) 580-4360


ICON Clinical Research
13131 Dairy Ashford
Suite 800
Sugar Land Houston, TX, 77478
US
Tel: +1 (281) 295 4800
Fax: +1 (281) 242 4890


Note: If you are a regulatory writing service provider in the United States and wish to be included in this list, please feel free to add your company information in the comments and we would be glad to add you here. Thank you.

If you wish to outsource your medical writing work to India, a destination considered to be considerably cheaper and want to know the names of companies in India providing such services please feel free to click here

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