Find Submissions Services for all your Submissions needs!
For more information, call 1-403-770-1994 or email us
Global Regulatory
The International Regulatory Outsourcing Network.
20 June 2013

Account Management

Welcome!
You are not logged in.

Regulatory Consulting Requests for Proposals
Regulatory Directories
Legal and Regulatory News
Regulatory Training and Conferences
 
 
Find Submissions regulatory consultants for all your Submissions consulting, audits and training such as regulatory submissions, regulatory compliance, advisory meetings, validation, regulatory actions, warning letters, import detentions, exporting, importing, seizures, non-approvals, FDA, Good Manufacturing Practices in countries such as the USA, Canada, Mexico, European Union, United Kingdom, Ireland, China, Japan, Australia, etc.

Submissions Requests for Proposals

Global Regulatory.com has received the following incoming Submissions Requests which need to be fulfilled ! These Submissions Requests are received from a variety of sources ranging from start-up companies to large, multinational corporations actively seeking companies to perform their Submissions services. If your company receives requests that it can not fulfill, please refer them to us! If you have questions, please e-mail us or call 403-770-1994 .
Incoming Submissions Requests
#
Submissions request description
status
13-0015 Medical Device Consultant needed for UK and USDA licenses and submissions for Poultry diagnostic tests licenced by USDA as is our UK and US facilities. We need to maintain this status and update pape ( read more ).....
12-000057 Canada Consumer Products Regulatory Consultant needed for regulatory submissions and compliance for Canada market for Mosquito Repellent Bracelet which active ingredient is natural essence, Citronella ( read more ).....
12-000051 US FDA Consultant needed for 510k Submission on LED heat lamp - Create a Risk Assessment or Risk Management Report in accordance with ISO 14971 including ongoing policies and practices needed for qual ( read more ).....
12-000002 In-Vitro diagnostics IVD FDA Regulatory consultant to assist with clinical trials and 510(k) submissions for FDA Class I and II devices. ( read more ).....
11-000053 FDA Regulatory Consultant needed for preparing FDA Investigational New Drug Applications, IND submissions for US-FDA. 1) Preparation of IND submission Dossier. 2) Gap analysis and review the prepared ( read more )..... Closed
11-00019 United States Medical Device Manufacturer owns a foreign manufacturer of rapid tests needs medical device consultant for Third Party Review or FDA submissions for 510K ASAP for Class II disposable fil ( read more )..... Closed
11-00016 REGULATORY CONSULTANT NEEDED FOR CTD DOSSIERS SUBMISSIONS TO DCA & LIASION FOR PRODUCT REGISTRATION ( read more )..... Closed
11-00008 United States Medical Device Manufacturer owns a China manufacturer of rapid tests needs medical device consultant for FDA submissions for OTC 510K ASAP for the following products froups): 1. Rapid ( read more )..... Closed
10-00168 Canada Pharmaceutical Consultant needed for Provincial formulary submissions for 5 solid oral dose products ( read more )..... Closed
10-00120 Regulatory Company needed for EC, AEMPS submissions for approval of clinical study approximately 3 sites in Spain ( read more )..... Closed
10-00082 Pharmaceutical Regulatory expert needed for NDA and drug monograph submissions for a natural product. ( read more )..... Closed
10-00062 Regulatory Consultant needed to submit protocol in Hungary, Spain, Italy and Austria. We will be able to supply the application for Belgium and France. We do not need the same person to be able to d ( read more )..... Closed
10-00037 INDIA PHARMACEUTICAL MANUFACTURER NEEDS PHARMACEUTICAL REGULATORY CONSULTANT FOR FDA SUBMISSIONS AND EUROPEAN COMMON TECHNICAL DOCUMENT EU CTD ( read more )..... Closed
10-00030 Asia based regulatory consultant needed to advise on regulatory requirements for Regulatory submissions in Japan ( read more )..... Closed
09-0120 Need Consultant for EU and US ANDA submissions ( read more )..... Closed
09-0035 Experienced FDA Regulatory Consultant needed to assist on FDA pharmaceutical regulatory submissions. ( read more )..... Closed
09-0034 Medical Writer needed with background in regulatory submissions to assist one of our clients in the Boston area. ( read more )..... Closed
09-0025 Clinical Trail Regulatory Consultant needed to advise on MOH Submissions and regulatory process in Belize. For example, how does the MOH submission take place and then does an IRB approve the study? ( read more )..... Closed
08-0054 Regulatory consultant needed to advise on pharmaceutical submissions ( read more )..... Closed
08-0023 Regulatory consultants needed for GMP, FDA & EU submissions ( read more )..... Closed
08-0003 FDA Pharmaceutical Regulatory Consultant needed for ANDA preparation and submission. Consultant must have experience with FDA and must have been successful on gaining approval on FDA submissions. ( read more )..... Closed
07-0133 Leading Global Medical Devices organistion requires regulatory consultant for urgent assistance required in writing, compiling and filing 510K submissions of various products. You must be able to hit ( read more )..... Closed
07-0101 Regulatory consultant needed to provide training programmes for ectd submissions ( read more )..... Closed
06-0102 Sponsor needs consultants for preparing Annual Product Reports, Product Renewals and post-approval submissions in CTD format ( read more )..... Closed
06-0101 Biologics regulatory consultants experienced with vaccines and cell culture processes needed to prepare submissions for several adenovector based veterinary vaccines. We are anticipating that our Reg ( read more )..... Closed
06-0093 Pharmaceutical manufacturer needs a consulting firm that to assist in registering and licensing pharmaceutical products, preparing submissions and dossiers in multiple countries in Asia (Thailand,Viet ( read more )..... Closed
06-0092 Pharmaceutical regulatory consultants needed for assistance in compilation and filing of dossier submissions for registration of generic pharmaceuticals in Japan. Familiarity with Biostudies, English ( read more )..... Closed
06-0084 Regulatory consultant needed for advising on nutraceutical product submissions to the SSA and the importing information for nutraceuticals into Mexico ( read more )..... Closed
06-0072 Regulatory consultant needed for assisting in e-Submissions across the globe including ANDA, NDA and BLS's. Also kindly let us know whether you have any tools to cater to the e-submissions for ANDA, N ( read more )..... Closed
06-0034 Regulatory consultants needed for SID filings for Low-Acid Canned Food (LACF) submissions for pickles packaged in bottles. ( read more )..... Closed
05-0044 Clinical Trials Consultant needed to consult on Regulatory requirements for clinical study submissions for both Ethiopia and Gambia"" ( read more )..... Closed
05-0018 EU Medical Device Regulatory Consultant needed for consulting on EU registration submissions of wound healing gel as medical device in Europe."" ( read more )..... Closed

For more information on Submissions services, please call 1-403-770-1994 or email us

Submissions Related News
New FDA guidance on considerations used in device approval, de novo decisions
2012-04-01 00:00:00
Clinical data, risks, benefits and patient risk tolerance outlined in proce... 

FDA and industry reach agreement in principle on medical device user fees
2012-02-01 00:00:00
The FDA and representatives from the medical device industry have reached a... 

TGA reforms: a blueprint for TGA's future
2011-12-08 00:00:00
Government to improve regulation of therapeutic goods media release, The ... 


US Food and Drug Adminsitration US FDA seeks comment on proposed guidelines for high-quality clinical studies
2011-08-15 00:00:00
The US Food and Drug Administration FDA today issued draft guidance to help... 

Press Release
2007-11-27 00:00:00
30-day extension to run through Dec. 26, 2007 The Food and Drug Administ... 

Press Release
2007-11-08 00:00:00
Reduces Risk of Pneumonia for Patients Using Ventilators The U.S. Food a... 

Press Release
2007-10-04 00:00:00
The U.S. Food and Drug Administration today outlined a program aimed at inc... 

Press Release
2006-05-31 00:00:00
The European Commission (EC), the European Medicines Agency (EMEA) and the ... 

Press Release
2006-05-22 00:00:00
New Guidelines for Use of Bayesian Statistics in Clinical Trials Issued as ... 

Press Release
2006-05-22 00:00:00
The U.S. Food and Drug Administration (FDA) is launching the Medical Device... 

Press Release
2005-12-23 00:00:00
As part of its continuing initiative to provide Americans with the informat... 

Press Release
2005-12-07 00:00:00
Public Meeting Brings Together Experts to Assess Risk Communication Tools a... 

Press Release
2004-06-01 00:00:00
CDRH revised the guidance entitled, "Validation Data in Premarket Notificat... 

Global Regulatory .com values your privacy. For more information on our Privacy Policy, please visit Privacy Policy This site is owned and managed by Global Regulatory, Inc.

Please also visit Contract Laboratory.com,, Contract Clinical.com