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Global Regulatory
The International Regulatory Outsourcing Network.
08 September 2010

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Regulatory Consulting
Regulatory Requests
 
Find Submission regulatory consultants for all your Submission 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.

Submission Requests for Proposals

Global Regulatory.com has received the following incoming Submission Requests which need to be fulfilled ! These Submission Requests are received from a variety of sources ranging from start-up companies to large, multinational corporations actively seeking companies to perform their Submission 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 Submission Requests
#
Submission request description
status
10-00121 Regulatory Company needed for FDA ANDA Submission, EU CTD, FDA GMP Vendor Audit, ISO Compliance, Validation & Qualification, Import/Export, Labeling and Advertising Reviews, Quality Systems, SOP Writi ( read more ).....
FDA ANDA Submission, EU CTD, FDA GMP Vendor Audit, ISO Compliance, Validation & Qualification, Import/Export, Labeling and Advertising Reviews, Quality Systems, SOP Writing, Process Development, Techn ( read more ).....
10-00120 Regulatory Company needed for EC, AEMPS submissions for approval of clinical study approximately 3 sites in Spain ( read more ).....
10-00115 Regulatory Consultants needed for preparation of documents for submission for registration of dietary and herbal supplements to the local FDA in Trinidad and Tobago ( read more ).....
10-00082 Pharmaceutical Regulatory expert needed for NDA and drug monograph submissions for a natural product. ( read more ).....
10-00078 India Pharma needs Regulatory Consultant for FDA ANDA Submission, Regulatory fillings ( read more )..... Closed
10-00077 California Pharmaceutical Corp needs regulatory Consultant for FDA ANDA submission and OTC ANDA submission. ( read more ).....
10-00074 part time regulatory consultant in Japan needed to oversee building of lab as well as submission of about 18 skus to the Ministry of Health. This person should be bilingual and have worked with cosm ( read more )..... Closed
10-00069 Medical Device Manufacturer needs FDA Regulatory Consultant for 510K approval Classification Panel: Radiology Diagnostic Devices Classification name: Positron Camera, Class I, 21 CFR § 892.1110 Pr ( read more )..... Closed
10-00064 Regulatory Consultant needed for regulatory advice / local document review / submission support for an observational, non-drug trial to be conducted by one of our Sponsors ( 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 ).....
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 ).....
09-0176 Clinical Trial Regulatory COnsultat with expertise in Colombia who can provide guidance on what is required for submission (IND equivalent) to INVIMA for conduct of a clinical study. ( read more )..... Closed
09-0170 Medical Device Regulatory Consultant needed for FDA 510K and CE submission for Class IIa medical devices. ( read more )..... Closed
09-0167 Regulatory consultant in Congo is required for the submission of biosimilar product registration in Congo. ( read more )..... Closed
09-0153 Medical Devices Manufacturer needs medical device consultant to advise on class II diode laser, 980nm machine for submission. ( read more )..... Closed
09-0143 Prague Company needs Regulatory Consultant for Product filling and fees arrangements in Slovenia. We are planning for submission of our product in Slovenia, need help to arrange communication with the ( read more )..... Closed
09-0124 Singapore Pharmaceutical Company needs Regulatory Consultant for Saudi Arabia Health Authority Regulatory submission for drug registration ( read more )..... Closed
09-0120 Need Consultant for EU and US ANDA submissions ( read more )..... Closed
09-0086 Regulatory consultant needed that can provide assistance with Russian technical submission and act as local authorised representative. ( read more )..... Closed
09-0082 Regulatory Consultants needed to advise on requirements for Montenegro pharmaceutical DMF submission ( read more )..... Closed
09-0081 Pharmaceutical Mfg needed FDA Consultants for FDA ANDA submission for injectable ( read more )..... Closed
09-0076 US FDA Consultants needed for FDA 510K submission of synthetic medical devices (surgical gloves) ( read more )..... Closed
09-0061 Pharmaceutical Mfg needs Regulatory Consultant for assisting on FDA submission ( read more )..... Closed
09-0037 "Pharmaceutical Regulatory consultants needed for dossier submission in Mexico, Canada and Latin America Region. ( 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
08-0167 Cosmetics Consultant needed for advising on compliance for cosmetics clinical trial submission in Europe for proper guidance/directive/legislation ( read more )..... Closed
08-0083 Pharmaceutical Regulatory Consultants with experience in US IND Maintenance needed to introduce Change Control Procedures (CCP) to R&D line functions to assure compliance with the requirements at 21CF ( read more )..... Closed
08-0074 Pharmaceutical Regulatory Consultant needed to conduct initial GMP/GLP mock inspection, advice on corrections necessary to ensure FDA approval, and then submission of ANDA for a generic drug. ( read more )..... Closed
08-0068 Pharmaceutical Manufacturer needs pharmaceutical regulatory consultant for submission of a drug dossier to the Brazilian Health Authorities ( read more )..... Closed
08-0054 Regulatory consultant needed to advise on pharmaceutical submissions ( read more )..... Closed
08-0048 Experienced US FDA consultant needed that is familiar with putting together a De Novo or ANDA specifically for anti-microbial hand soaps for a suite of 3 proven anti-microbial handsoaps and rubs that ( read more )..... Closed
08-0031 Pharmaceutical regulatory consultant needed to help with pharmaceutical US FDA ANDA Submission ( 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
07-0144 Regulatory Consultants needed for GMP training and preparation of EU submission for veterinary medicines ( read more )..... Closed
07-0143 Dietary Supplement Manufacturing Company of 45 products is looking for FDA consulting services in these areas:  Reviewing dietary supplement labels for compliance with FDA regulations.  Evalu ( 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
07-0103 Regulatory consultants needed to develop Regulatory Strategy and FDA submission for InVitro Diagnostic Assays ( read more )..... Closed
07-0101 Regulatory consultant needed to provide training programmes for ectd submissions ( read more )..... Closed
07-0089 Pharmaceutical consultant needed to represent client at MOH meetings, discuss optimal strategy for registration of pharmaceuticals with MOH;hands on activities with respect to dossier compilation and ( read more )..... Closed
07-0053 Regulatory and clinical trial consultancy required for FDA submission of ultrasound based CAD system. Experience and expediency with imaging sector device and software must be demonstrable. ( read more )..... Closed
07-0046 Assistance in preparation of USFDA DMF submission for pharmaceutical raw material, GMP assistance and audit preparation for USFDA audit. ( read more )..... Closed
07-0043 Medical diagnostics test developer needs FDA consulting expertise to include statistical data design and FDA submission expertise ( read more )..... Closed
07-0042 Medical Device Manufacturer needs Regulatory Consulting Firm to advise on current regulations regarding submission for new medical device in South Africa ( read more )..... Closed
07-0041 Regulatory Consulting Firm needed for Class II Medical Device Submission. ( read more )..... Closed
07-0028 Regulatory consultant needed for help getting a regulatory review/submission for sale of products into Canada and Mexico. ( read more )..... Closed
07-0013 Pharmaceuticals Consultant needed for the assistance on the development and submission of new labelling for new pharmaceutical products based on existing approved ANDA's. ( read more )..... Closed
06-0111 Regulatory consultant needed for Canada oncology New Drug Submission (NDS) NDS in TPD, Canada. ( 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
06-0099 Clinical Trial Consultant needed for consulting on phase I, II, III and IV clinical trials in Cyprus, Israel, Botswana, Bahamas, Luxembourg, El Salvador, Jamaica, New Zealand, Turkey, Uruguay and Bulg ( 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
06-0045 Vaccines and immuno-biologics manufacturer needs regulatory consultants for generation of regulatory submission data for method validations of biologicals ( 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
05-0064 Experienced Pharmaceutical Regulatory Consultant needed to assist RA Manager in reviewing content and assembling ANDA for submission in early January" ( 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 Submission services, please call 1-403-770-1994 or email us

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