blog.assurx.com
Product News
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August 21, 2016. Compliance, quality and risk: Straight talk for regulated industries. SaaS & Cloud Computing. You are here: Home. Introducing AssurX One: A complete, affordable, single source compliance solution for small- to medium-sized utility companies. April 28, 2011. Built-in metrics, robust help files and an easy dashboard-centric user interface require minimal training to get up and running quickly. Included in the AssurX One program:. Hosted on a secure, OnDemand system with preloaded NERC and ...
blog.assurx.com
eMDR Updates
http://blog.assurx.com/category/fda-regulated/emdr-updates
August 21, 2016. Compliance, quality and risk: Straight talk for regulated industries. SaaS & Cloud Computing. You are here: Home. Archives for FDA Regulated. FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures. July 14, 2015. Michael Causey, Editor-in-Chief,. Association of Clinical Research Professionals. It’s been a little while since we checked the FDA’s outgoing mail tray to find out what inspectors are looking for and often finding during their visits in the first half of 2015. As minor a...
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Electric Reliability
http://blog.assurx.com/category/electric-reliability
August 21, 2016. Compliance, quality and risk: Straight talk for regulated industries. SaaS & Cloud Computing. You are here: Home. Archives for Electric Reliability. Large Utilities Power Up with AssurX Enterprise GRC Solution. June 4, 2015. Tamar June, VP, Strategic Marketing, AssurX, Inc. Says a new report from Blue Hill Research. The white paper, Anatomy of a Decision. And the Federal Energy Regulatory Commission (FERC). If one of the GRC carrots is increased efficiency and a stronger competitive post...
goodpromotionalpractices.com
Regulatory | Good Promotional Practices
http://goodpromotionalpractices.com/category/regulatory
Best Collaborative Practices for Sales, Marketing and Regulatory. Stop Making Sense: Aggregate Spend Reporting. July 21, 2011. Guest Author: Jeff Gaus. Disclosure: Prolifiq is a sponsor of goodpromotionalpractices.com. I spent two days in Chicago at the Q1 Productions Pharmaceutical and Medical Device Sales and Marketing Compliance seminar. Approximately 80 senior executives of the who’s who in life sciences regulatory compliance participated. Rarr; 5 Comments. July 12, 2011. Said Suzanne Rich Folsom.
srcteam.com
Reference Library | Strategic Regulatory Consulting | Toxicology Consulting
http://srcteam.com/library
Safety & Toxicology. OSHA & EPA. Azar M. Hazrati. Reference Library and Useful Links. Reference Library & Useful Links. The mission of BioOhio is to accelerate bioscience discovery, innovation, and commercialization of global value, driving economic growth and improved quality of life in Ohio. BioOhio, founded in 1987 as Edison BioTechnology Center and formerly Omeris, is. Global RPh (searchable reference). Clinicians ultimate reference. Search Medical Terminology, Dosing, Drug Tables, Lab Values, etc.
texingc.com
Texin Global Consulting, LLC.
http://www.texingc.com/links.html
Texin Global Consulting, LLC. Regulatory Affairs and Compliance Specialist. US Food and Drug Administration. FDA, Medical Devices. ISO - International Organization for Standardization. The Food and Drug Law. Regulatory Affairs Professionals Society. AICHE - American Institute of Chemical Engineers. United States Patent and Trademark Office. United States International Trade Commission. TEXIN GLOBAL CONSULTING is a full-service, international agency dedicated to preparation of regulatory documents.
texingc.com
Texin Global Consulting, LLC.
http://www.texingc.com/index.html
Texin Global Consulting, LLC. Regulatory Affairs and Compliance Specialist. Our services include :. Investigational New Drug Applications (INDs),. Investigational Medicinal Product Dossier (IMPD),. Clinical Trial Applications (CTAs),. Biologic License Applications (BLAs),. Marketing Authorization Applications (MAAs),. New Drug Applications (NDAs). Creating Electronic Common Technical Documents (eCTD). Investigator brochures and updates. Pediatric Study Plans (PSPs, PIPs). Clinical summaries and overviews.
gcphelpdesk.com
Good Clinical Practice (GCP) Helpdesk, Clinical Trial Guidelines, Training
http://www.gcphelpdesk.com/helpdesk
Need an answer to your GCP query? Post your query at HelpDesk * *. Q of the week. Q: What are the possible benefits and risks of clinical trials? Invanz is a once-daily injectable antibiotic approved for use in adults for the treatment of moderate to severe infections caused by common gram-positive and gram-negative aerobic and anaerobic bacteria. Included, are community-acquired pneumonia, intra-abdominal, skin, urinary tract, kidney and post-surgical gynecological infections. Ask your GCP Expert.
blog.assurx.com
Success Stories
http://blog.assurx.com/category/success-stories
August 21, 2016. Compliance, quality and risk: Straight talk for regulated industries. SaaS & Cloud Computing. You are here: Home. Archives for Success Stories. Angiotech Leverages SaaS Model for Global Complaint Handling System to Standardize and Improve Efficiency. July 21, 2009. The concept of implementing SaaS. That may be why Angiotech. Made the decision to go with AssurX’s OnDemand. SaaS) model as opposed to on-premise implementation for their global complaint handling system. 8220;We got the bless...
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Uncategorized
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August 21, 2016. Compliance, quality and risk: Straight talk for regulated industries. SaaS & Cloud Computing. You are here: Home. FDA Lifts Curtain on Inspection Process, Rationale. March 25, 2010. Michael Causey, Editor and Publisher, eDataIntegrityReport.com. Gotta give the FDA. As an aside, Rogers also said that the agency currently has about 1,800 total inspectors across its full portfolio, though food gets the bulk of the bodies. He also said there will be more foreign inspections this year, an...
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