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Home - GMP Scientific

GMP Scientific Inc. is a global consulting firm organized to provide comprehensive services for FDA-regulated companies

http://www.gmpscientific.com/

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GMP Scientific Inc. is a global consulting firm organized to provide comprehensive services for FDA-regulated companies
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GMP Scientific Inc. is a global consulting firm organized to provide comprehensive services for FDA-regulated companies

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1

References | GMP Scientific Inc.

http://www.gmpscientific.com/references.php

FDA Enforcement Guidance Link. ICH Guidance Documents Link (Q Series). To our Client Portal to view and download useful articles and links.

2

Testimonials | GMP Scientific Inc.

http://www.gmpscientific.com/testimonials.php

Brings different, unique perspective to the project keeping the client in focus.has good understanding of FDA regulations.will not only tell you what is wrong but also tell how to fix the deficiencies which is rare.". Professionals, with a genuine passion for compliance and business process improvement.". To our Client Portal to view and download useful articles and links.

3

Blog | GMP Scientific Inc.

http://www.gmpscientific.com/blog.php

Can honesty be taught? We see a lot of articles, seminars, webinars, presentations on the internet these days. Many tout to inform you and yours on the ills of Data Integrity issues. Sure this makes these services a quick buck, but seriously, can honesty be taught? What do you think? By Sam Pandit on 09/16/2014 @ 2:43 PM. What to do about BDIs (Breaches of Data Integrity). Here is what the FDA says in a Warning Letter:. 5 Use organizational charts and SOPs to identify the specific managers in place when ...

4

Services | GMP Scientific Inc.

http://www.gmpscientific.com/services.php

Corrective and Preventive Action Development. Standard Operating Procedures Development. FDA 483 and Warning Letter Response and Remediation. Data Review and Verification. To our Client Portal to view and download useful articles and links.

5

Employment | GMP Scientific Inc.

http://www.gmpscientific.com/employment.php

If's you have worked in the FDA Regulated Industry with over 15 years, or with the US FDA previously, we would love to hear from you. Team oriented professional work environment. If interested, please send us an email with a detailed resume/CV to employment@gmpscientific.com. Join our team and help us make a difference.

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GMP Executive: January 2008

http://gmpexecutive.typepad.com/my_weblog/2008/01/index.html

Engage, Enable, Execute! FDA - How to's. Peter Ferdinand Drucker: The Effective Executive: The Definitive Guide to Getting the Right Things Done (Harperbusiness Essentials). One of the best books on Management. Subscribe to this blog's feed. See how we're connected. We help clients meet FDA regulations effectively at an affordable rate. We only employ Ex-FDA employees and senior Industry experts. Visit us on our website for more information. www.GMPScientific.com. February 2008 ». January 31, 2008. This ...

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GMP Executive: People

http://gmpexecutive.typepad.com/my_weblog/people

Engage, Enable, Execute! FDA - How to's. Peter Ferdinand Drucker: The Effective Executive: The Definitive Guide to Getting the Right Things Done (Harperbusiness Essentials). One of the best books on Management. Subscribe to this blog's feed. See how we're connected. We help clients meet FDA regulations effectively at an affordable rate. We only employ Ex-FDA employees and senior Industry experts. Visit us on our website for more information. www.GMPScientific.com. March 22, 2008. Follow Where You Lead.

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GMP Executive: March 2008

http://gmpexecutive.typepad.com/my_weblog/2008/03/index.html

Engage, Enable, Execute! FDA - How to's. Peter Ferdinand Drucker: The Effective Executive: The Definitive Guide to Getting the Right Things Done (Harperbusiness Essentials). One of the best books on Management. Subscribe to this blog's feed. See how we're connected. We help clients meet FDA regulations effectively at an affordable rate. We only employ Ex-FDA employees and senior Industry experts. Visit us on our website for more information. www.GMPScientific.com. Laquo; February 2008. April 2008 ».

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GMP Executive: Follow Where You Lead

http://gmpexecutive.typepad.com/my_weblog/2008/03/follow-where-yo.html

Engage, Enable, Execute! FDA - How to's. Peter Ferdinand Drucker: The Effective Executive: The Definitive Guide to Getting the Right Things Done (Harperbusiness Essentials). One of the best books on Management. Subscribe to this blog's feed. See how we're connected. We help clients meet FDA regulations effectively at an affordable rate. We only employ Ex-FDA employees and senior Industry experts. Visit us on our website for more information. www.GMPScientific.com. Responding to the Warning Letter ».

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GMP Executive

http://gmpexecutive.typepad.com/my_weblog

Engage, Enable, Execute! FDA - How to's. Peter Ferdinand Drucker: The Effective Executive: The Definitive Guide to Getting the Right Things Done (Harperbusiness Essentials). One of the best books on Management. Subscribe to this blog's feed. See how we're connected. We help clients meet FDA regulations effectively at an affordable rate. We only employ Ex-FDA employees and senior Industry experts. Visit us on our website for more information. www.GMPScientific.com. February 24, 2009. Posted at 10:35 AM.

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September | 2014 | Pharmannex

https://pharmannex.wordpress.com/2014/09

News, Views, and Ideas on Health and Wellbeing. Top 10 Reasons for FDA 483 Observations. Shire’s New Eating Disorder Drug Gets Expedited Review. Breaches of Data Integrity – Here’s what the US FDA said in a recent 483. Top 10 Reasons for FDA 483 Observations. Here’s a list of TOP TEN FDA Observations for Pharmaceutical Companies between the years 1998 and 2010. While this information is somewhat dated, it is still very relevant. Written Procedures Not Followed Or Documented. Laboratory Controls do not in...

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Top 10 Reasons for FDA 483 Observations | Pharmannex

https://pharmannex.wordpress.com/2014/09/21/top-10-reasons-for-fda-483-observations

News, Views, and Ideas on Health and Wellbeing. Top 10 Reasons for FDA 483 Observations. Shire’s New Eating Disorder Drug Gets Expedited Review. Breaches of Data Integrity – Here’s what the US FDA said in a recent 483. Top 10 Reasons for FDA 483 Observations. Here’s a list of TOP TEN FDA Observations for Pharmaceutical Companies between the years 1998 and 2010. While this information is somewhat dated, it is still very relevant. Written Procedures Not Followed Or Documented. Laboratory Controls do not in...

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pharmannex | Pharmannex

https://pharmannex.wordpress.com/author/pharmannex

News, Views, and Ideas on Health and Wellbeing. Top 10 Reasons for FDA 483 Observations. Shire’s New Eating Disorder Drug Gets Expedited Review. Breaches of Data Integrity – Here’s what the US FDA said in a recent 483. Top 10 Reasons for FDA 483 Observations. Here’s a list of TOP TEN FDA Observations for Pharmaceutical Companies between the years 1998 and 2010. While this information is somewhat dated, it is still very relevant. Written Procedures Not Followed Or Documented. Laboratory Controls do not in...

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HELPING OUR CLIENTS BUILD ROBUST QUALITY SYSTEMS. SUSTAINABLE FDA COMPLIANCE PROGRAM. COST EFFECTIVE and CUSTOMIZED SOLUTIONS. Welcome To GMP Scientific, Inc. GMP Scientific, Inc. Consulting firm organized to provide comprehensive services for FDA-regulated companies. We provide cost effective and customized solutions to our clients in maintaining sustainable regulatory compliance and a robust Quality System thereby ensuring a healthy and viable enterprise. A Brave New World. Can honesty be taught?

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