Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959
 info@antrix.com

Press

Following are the press releases. The white papers are available by sending request to info@antrix.com

Press Releases

  1. Interview by Pharmaceutical Processing magazine on Electronic Signatures and Data Quality
    Article published in Pharm Pro, a leading pharamecuitical technology news magzine on "Electronic Signatures and Data Quality"  - May 2009

  2. CNN News Article on "Another Johnson & Johnson drug plant gets flagged"
    Expert comments featured in CNN News Article on "Another Johnson & Johnson drug plant gets flagged"

  3. Electronic Regulatory Submissions Gateway in the US and EU
    Article on Electronic Regulatory Submissions Gateway in the US and EU. Article published in RAPS Focus Magazine - March 2009

  4. Electronic Signatures and Digital Certificates in the US
    Article on Electronic Signatures and Digital Certificates requirements in the US. Article published in RAPS Focus Magazine - April 2009

  5. Electronic Submission for Medical Devices in the US and the EU
    Article on electronic submission for medical devices in the US and the EU. Article published in RAPS Focus Magazine - July 2009

  6. Electronic Regulatory Submissions and Review for Drugs and Medical Devices
    Co-author book on electronic regulatory submission and review for drugs and medical devices. To be published and released in December 2010.

  7. Electronic Regulatory Submissions and Review for Drugs and Medical Devices
    Thesis presented to regulatory affairs department faculty committee of San Diego State University.

  8. Regulatory Management Simulation: "Strategic Regulatory Planning for Innovative Medical Devices and Diagnostics
    White paper providing an overview of the In Vitro Diagnostic Device (IVD) Protein Diagnostics regulatory plan to get the FDA approval. Subsequently company will apply for approval and market the product in EU, Japan, Canada and rest of the world.

  9. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
    White paper on provides guidance on the regulatory content and review of premarket submissions for software contained in medical devices. This paper explains the software level of concern determination and how it relates to device hazard analysis & risk mitigations and to the documentation submission. It discusses Risk Management activities associated during software development.

  10. The Manufacture and Control of Chemical and Biologic Active Pharmaceutical Ingredients (API’s).  
    White paper on Addressing Compliance to Current Good Manufacturing Practice (cGMP).

  11. Comparing Regulatory/Clinical Trial Similarities and Differences between the EU and Japan
    White paper on Comparing Regulatory/Clinical Trial Similarities and Differences between the EU and Japan.

  12. Due Diligence Audit Preparation
    White paper on how to prepare a biotechnology company supporting phase I and II clinical trials doing all clinical supplies manufacturing and testing internally for due diligence audit from potential partner.

  13. New Drug Product Development Plan
    White paper on APC 1000 drug product development plan to demonstrate efficacy and providing evidence of the safety in the study population and subsequently to the FDA approval of a new drug product.

  14. Tools and Technologies for Electronic Submissions
    Article on plug-ins, file system, servers, EDMS and publishing systems required for Electronic Regulatory Submissions for medical device and drugs.

  15. Electronic Submission Choices, Challenges and Solutions
    Article on global or national submission, regulatory document management, tools, technologies, personnel and life cycle requirements.

  16. Medical Device Adverse Event Reports and Drugs Post-marketing Adverse Events Reporting
    Article on logistics related to medical device and drugs adverse event reporting.

  17. Consent Decree Paper
    White paper on the Consent Decree against Schering-Plough Corporation, with a disgorgement fine of half a billion dollars by FDA and as to what steps the companies should have taken to avoid such a consent decree.

  18. How to handle FDA Warning Letters Issued to Biologics, Drug and Medical Device Companies?
    White paper on Warning letter issued to biologic, drug and medical device company in last 24 months and how they could have prevented the action from the regulatory agency.

  19. Advertising and Promotional Labeling Material
    Article on how to advertise and promote the device and drugs in the USA and EU.

  20. HIPAA Health Insurance Reform and Electronic Health Record Implementation
    White paper on HIPAA implications on clinical research, industry approach, challenges and relationship to FDA guidance on electronic records and signatures.

  21. Applied Unix Programming - Volume 1
    Volume 1 of a two-volume set, this comprehensive reference draws together into one convenient source all the background necessary for designing, writing, and testing portable UNIX applications within the framework of new standards. Example-oriented in approach, it covers Open Systems Evolution, the UNIX Model and Terminology, Software Development, Software Internationalization, Software Localization, and C and C++ programming languages.
  22. Applied Unix Programming - Volume 2
    Provides resources that reduce the time required to prototype, develop and test UNIX applications, and improve their reliability.This book contains descriptions of the most important UNIX library functions. It includes System Interfaces, including the core of the operating system service library, C library, International library and math library. It includes Transport service interfaces; Socket interfaces as defined by BSD; the IP Address Resolution Interface, and more.UNIX software developers, testers and students. Part of a 2 book series -- APPLIED UNIX PROGRAMMING VOLUME I, BK/DISK