Navigation Links
Successful FDA Inspection at AXIS Clinicals USA
Date:8/16/2017

We are proud to announce the successful completion of our third U.S. Food and Drug Administration (FDA) inspection at our Dilworth, MN site. The inspection took place Monday, July 31st through Friday, August 4th, 2017. No 483 was issued. This inspection was conducted as part of a routine Bioresearch Monitoring Program (BIMO) with the USFDA wherein multiple Dermatology Vasoconstriction Bioequivalence studies were reviewed by the inspector.

AXIS has completed 19 successful FDA inspections at our Hyderabad, India and Dilworth, MN sites for USFDA submission studies, including First-To-File and patient based clinical studies. This recent success is another accomplishment as it reinforces our commitment to Quality and International Regulatory Compliance.

“It feels great to have two successful FDA audits without a 483 issued in a span of less than three months. The most recent audit focused on Dermatology which has been a business focus for AXIS since our inception and we have invested heavily to build our capabilities and serve our customer’s needs. We are very pleased with the positive feedback given by the FDA regarding our staff competence, as well as the robust company processes and documentation practices.” –Dinkar Sindhu, CEO

About AXIS Clinicals

AXIS Clinicals USA, a full-service Contract Research Organization (CRO), is joined by other global sites, AXIS Mexico (Est. 2010) and AXIS India (Headquarters, Est. 2004). AXIS USA offers the conveniences of a purpose-built 120,000 square foot facility to handle multiple studies at once, including an in-house Bioanalytical lab capable of handling over 15,000 samples per month, an on-site Dermatology Center, and a fully licensed Pharmacy. Since opening in 2014, AXIS USA has conducted around 100 studies and dosed over 5,000 volunteers at our Dilworth, MN site. With our global locations, we offer the flexibility and convenience of working with one company across multiple countries.

Contact
To learn more about AXIS Clinicals, please contact: BD(at)AxisClinicalsUSA.com
USA: http://www.axisclinicalsusa.com Corporate: http://www.axisclinicals.com

Read the full story at http://www.prweb.com/releases/2017/08/prweb14603135.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related biology technology :

1. ACEA Biosciences Announces Successful Completion of Phase I Clinical Study of Novel Autoimmune Disease Drug
2. Grassroots Effort Proving Successful in Solving Multiple Sclerosis Puzzle
3. First Published Clinical Study Successfully Uses Precision Medicine To Predict Prescription Opioid Abuse
4. SkylineDx Presented New Algorithm Demonstrating Ability to Successfully Identify Gene Sets that are Informative of Cancer Treatment Specific Survival
5. RepliCels Successful RCT-01 Tendon Repair Clinical Trial Shows Signs of Healing Chronic Tendon Problems
6. Nanomedical Diagnostics Announces Partnership with Rogue Valley Microdevices, Delivering World’s First Successful High-Volume Manufacturing for Graphene Biosensors
7. JALA Group Announces Successful Printing of Asian Skin Using 3D Bioprinting Technology
8. Malaria Drug Successfully Treats 26-year-old Brain Cancer Patient
9. Resverlogix Announces Successful Phase 1 Renal Trial Results: Clears Path for Future Phase 2 Studies
10. ValGenesis Inc. Successfully Completes ISO 9001:2008 Surveillance Audit
11. BioLineRx Reports Successful Top-Line Results in Phase 2 Trial for AML
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... CA (PRWEB) , ... October ... ... a development-stage cancer-focused pharmaceutical company advancing targeted antibody-drug conjugate (ADC) therapeutics, today ... of targeted HPLN (Hybrid Polymerized Liposomal Nanoparticle), a technology developed in collaboration ...
(Date:10/10/2017)... Parks Associates announced today that Tom Kerber , Director ... , October 11 in Scottsdale, Arizona . Kerber will ... safety and security products impact the competitive landscape. ... Parks Associates: Smart Home Devices: Main Purchase Driver ... "The residential security market has experienced continued growth, and the introduction of ...
(Date:10/10/2017)... ... 10, 2017 , ... The Pittcon Program Committee is pleased ... scientists who have made outstanding contributions to analytical chemistry and applied spectroscopy. Each ... leading conference and exposition for laboratory science, which will be held February 26-March ...
(Date:10/9/2017)... Charlotte, N.C. (PRWEB) , ... October 09, 2017 , ... ... Purple announced Dr. Christopher Stubbs, a professor in Harvard University’s Departments of Physics and ... Dr. Stubbs was a member of the winning team for the 2015 Breakthrough Prize ...
Breaking Biology Technology:
(Date:8/23/2017)... Aug. 23, 2017  The general public,s help is being enlisted in ... that live in and on the human body –and are believed to ... The Microbiome Immunity Project ... microbiome, starting with the gut. The project's goal is to help advance ... IBM ...
(Date:7/20/2017)... Delta (NYSE: DAL ) customers now can use ... Reagan Washington National Airport (DCA). ... Delta launches biometrics to board aircraft at Reagan Washington ... Delta,s biometric boarding pass experience that ... integrated into the boarding process to allow eligible Delta SkyMiles Members who ...
(Date:6/23/2017)... ITHACA, N.Y. , June 23, 2017 ... a leader in dairy research, today announced a new ... help reduce the chances that the global milk supply ... this dairy project, Cornell University has become the newest ... Food Supply Chain, a food safety initiative that includes ...
Breaking Biology News(10 mins):