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MAGID-HAFFNER.COM

Magid-Haffner, Inc

With more than twenty-five years of experience as a global company, we at Magid-Haffner have associates that have regulatory expertise in the EU, US, Japan, India and China for Pharmaceutical, Biotech and Medical Devices. We provide the following services:. FDA and EMEA submissions. FDA Pre-Approval (PAI) mock audits. SOP writing and documentation review. Deviation and CAPA investigations.

http://www.magid-haffner.com/

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CONTACTS AT MAGID-HAFFNER.COM

magid-haffner assoc.inc.

4400 ke●●●●●●●e drive

ale●●●ria , VA, 22310

US

1.70●●●●3988
1.70●●●●3681
pe●●●●●@MAIL.IDT.NET

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Magid Haffner Associates Inc.

Peine, Ira

4400 Ke●●●●●●●oke Dr.

Ale●●●ria , VA, 22310

US

1.70●●●●3988
1.99●●●●9999
ip●●●●@magid-haffner.com

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Magid Haffner Associates Inc.

Peine, Ira

4400 Ke●●●●●●●oke Dr.

Ale●●●ria , VA, 22310

US

1.70●●●●3988
1.70●●●●3681
ip●●●●@magid-haffner.com

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Magid-Haffner, Inc | magid-haffner.com Reviews
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With more than twenty-five years of experience as a global company, we at Magid-Haffner have associates that have regulatory expertise in the EU, US, Japan, India and China for Pharmaceutical, Biotech and Medical Devices. We provide the following services:. FDA and EMEA submissions. FDA Pre-Approval (PAI) mock audits. SOP writing and documentation review. Deviation and CAPA investigations.
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2 founder
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6 about us
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Magid-Haffner, Inc | magid-haffner.com Reviews

https://magid-haffner.com

With more than twenty-five years of experience as a global company, we at Magid-Haffner have associates that have regulatory expertise in the EU, US, Japan, India and China for Pharmaceutical, Biotech and Medical Devices. We provide the following services:. FDA and EMEA submissions. FDA Pre-Approval (PAI) mock audits. SOP writing and documentation review. Deviation and CAPA investigations.

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magid-haffner.com magid-haffner.com
1

GXP Training « Magid-Haffner, Inc

http://www.magid-haffner.com/gxp-training

Our Training the Trainer Program. Provides the implementation of a documentable training program, from operator level through management level personnel and meets U.S. and International professional and regulatory requirements. Magid-Haffner Associates, Inc. offers customized training programs for pharmaceutical, biotech and device companies. Our training programs cover:. Good Manufacturing Practice (GMP) for:. Good Clinical Practice (GCP) for:. Phase I II – III Clinical services.

2

Founder « Magid-Haffner, Inc

http://www.magid-haffner.com/founder

Educated at St. Mary’s University in San Antonio, Texas, he earned a Bachelor of Arts degree in Chemistry, Biology and Philosophy. As an independent consultant since 1983, his duties have included the management, as president, of MAGID – HAFFNER ASSOCIATES, INC., an international consulting firm that specializes in; Quality Assurance implementation, Regulatory Affairs documentation, cGMP training, and manufacturing process documentation. Journal of Parenteral Science and Technology, March 1982.

3

Links Of Interest « Magid-Haffner, Inc

http://www.magid-haffner.com/links-of-interest

United States Food and Drug Administration. Medicines and Healthcare products Regulatory Agency. Heads of Medicines Agencies. Bundesinstitut für Arzneimittel und Medizinprodukte. State Food and Drug Administration, P.R. China. European Directorate for the Quality of Medicines. Compliance should improve the overall quality and efficiency of the operation while achieving compliance and having a positive impact on the corporation's bottom line.".

4

About Us « Magid-Haffner, Inc

http://www.magid-haffner.com/about-us

Magid-Haffner Associates, Inc. As a global company we have associates that have regulatory expertise in the EU, US, Japan, India and China and can support FDA and EMEA submissions. We are the U.S. Agent for several foreign API companies and Magid-Haffner Associates, Inc. is located within one hour of the FDA campus in Rockville, MD. Magid-Haffner Associates, Inc. has provided guidance to clients. By conducting FDA/EMEA International GMP Compliance Audits for API, sterile and non-sterile drug products.

5

Mission « Magid-Haffner, Inc

http://www.magid-haffner.com/mission

Our philosophy on CGMP compliance is simple:. Our mission is to provide the best Quality Assurance and Regulatory Affairs expertise available by offering individualzed solutions that are effective and efficient for your company’s needs. Compliance should improve the overall quality and efficiency of the operation while achieving compliance and having a positive impact on the corporation's bottom line.".

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