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compliance-specialistsllc.com

Compliance Specialist, LLC

Consulting services to support Pharmaceutical and Medical Device Companies with FDA compliance, quality systems and e submissions.

http://www.compliance-specialistsllc.com/

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Compliance Specialist, LLC | compliance-specialistsllc.com Reviews
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Consulting services to support Pharmaceutical and Medical Device Companies with FDA compliance, quality systems and e submissions.
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Compliance Specialist, LLC | compliance-specialistsllc.com Reviews

https://compliance-specialistsllc.com

Consulting services to support Pharmaceutical and Medical Device Companies with FDA compliance, quality systems and e submissions.

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1

eSubmissions – Compliance Specialist, LLC

http://www.compliance-specialistsllc.com/esubmissions.html

Program development from design to implementation. E-Submissions for Pharmaceutical Companies. As of June, 2009, NDC code requests, establishment registrations, and drug listings must be submitted to FDA electronically using extensible markup language (XML) in SPL format (Refer to FDA’s Guidance for Industry, Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing). E-Submissions for Medical Device Companies.

2

Consulting Services – Compliance Specialist, LLC

http://www.compliance-specialistsllc.com/consulting-services.html

Program development from design to implementation. I’ve been asked many times by potential clients Why do I need a consultant? I always respond with the same question.how are your quality systems working for you? I would ask the same thing of the visitors to my Website. How are your quality systems working for you? Are the same deviations showing up time after time in your corrective action data base? Do you have deviation investigations that have been open over 45 days? If so, the CAPA system isn’t work...

3

SOP Library – Compliance Specialist, LLC

http://www.compliance-specialistsllc.com/sop-library.html

Program development from design to implementation. CSLLC maintains an extensive library of standard operating procedures. These are available to purchase to clients. Data collection forms that are used to record quality data are also available for the SOPs that require them. Investigation of Process/Product Deviations (including immediate response to, and management of, deviations to minimize long term effect and risk),. Managing Corrective and Prevent Actions (to assure the root cause is resolved),.

4

Compliance Specialist, LLC

http://www.compliance-specialistsllc.com/index.html

Program development from design to implementation. Compliance Specialists, L.L.C. provides a wide range of consulting services to support Pharmaceutical and Medical Device Companies. Compliance Specialists, L.L.C will provide your company with consulting services that are personal, efficient, and suitable to your level of resources. I look forward to hearing from you to discuss your needs and the services that Compliance Specialists, L.L.C. can offer your company.

5

Compliance Specialists LLC Blog

http://www.compliance-specialistsllc.com/blog

Compliance Specialists LLC Blog. Program development from design to implementation. I’ve been asked many times by potential clients Why do I need a consultant? I always respond with the same question…how are your quality systems working for you? I would ask the same thing of the visitors to my Website. How are your quality systems working for you? FDA Compliance and Enforcement Actions.

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