enemconsulting.com enemconsulting.com

enemconsulting.com

:: ENEM CONSULTING ::

ENEM Consulting LLC is a life sciences regulatory consulting company providing clients with comprehensive regulatory, quality and clinical services. Seamless blending of strategy with execution. Regulatory and Project Planning. FDA Communication and Submission Management. Clinical Planning, Strategy and Operations.

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:: ENEM CONSULTING :: | enemconsulting.com Reviews
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ENEM Consulting LLC is a life sciences regulatory consulting company providing clients with comprehensive regulatory, quality and clinical services. Seamless blending of strategy with execution. Regulatory and Project Planning. FDA Communication and Submission Management. Clinical Planning, Strategy and Operations.
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1 medical devices
2 ivds
3 combination products
4 about us
5 regulatory support
6 clinical/quality systems
7 who we are
8 flexible and efficient
9 multi disciplinary expertise
10 regulatory
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medical devices,ivds,combination products,about us,regulatory support,clinical/quality systems,who we are,flexible and efficient,multi disciplinary expertise,regulatory,regulatory strategy,regulatory submissions,due diligence,clinical support,cro audits
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:: ENEM CONSULTING :: | enemconsulting.com Reviews

https://enemconsulting.com

ENEM Consulting LLC is a life sciences regulatory consulting company providing clients with comprehensive regulatory, quality and clinical services. Seamless blending of strategy with execution. Regulatory and Project Planning. FDA Communication and Submission Management. Clinical Planning, Strategy and Operations.

INTERNAL PAGES

enemconsulting.com enemconsulting.com
1

:: ENEM CONSULTING ::

http://www.enemconsulting.com/croa.html

Clinical and Quality Systems support. Regulatory and Project Planning. FDA Communication and Submission Management. Clinical Planning, Strategy and Operations. Contract Research Organization (CRO) Audits. Conducted on behalf of the sponsor, the audits help ensure that the CRO is in compliance with Good Clinical Practice (GCP) regulations and will include:. Verifying adherence to program specific procedures outlined in the clinical research protocol(s) and contractual agreements. 21 CFR Part 11 assessments.

2

:: ENEM CONSULTING ::

http://www.enemconsulting.com/glp.html

Clinical and Quality Systems support. Regulatory and Project Planning. FDA Communication and Submission Management. Clinical Planning, Strategy and Operations. Conducted on behalf of the sponsor, the audits help ensure that the test laboratory is in compliance with Good Laboratory Practice (GLP) regulations and will include:. Verifying adherence to program specific procedures outlined in the animal research protocols, to ISO 10993 requirements and contractual agreements.

3

:: ENEM CONSULTING ::

http://www.enemconsulting.com/qsd.html

Regulatory and Project Planning. FDA Communication and Submission Management. Clinical Planning, Strategy and Operations. Quality Systems development to FDA QSr and ISO 13485 regulations including:. Developing Standard Operating Procedures (SOPs). Developing and managing project plan for Quality Systems implementation.

4

:: ENEM CONSULTING ::

http://www.enemconsulting.com/cpso.html

Regulatory and Project Planning. FDA Communication and Submission Management. Clinical Planning, Strategy and Operations. Clinical Study Strategy, Planning and Operations. Clinical study design (Pilot and Pivotal). Standard Operating Procedure (SOP) development. Regulatory review of Protocol, Statistical plan.

5

:: ENEM CONSULTING ::

http://www.enemconsulting.com/fcs.html

Regulatory and Project Planning. FDA Communication and Submission Management. Clinical Planning, Strategy and Operations. FDA Communication and Submission Management. Services include assistance with FDA meetings, teleconferences and FDA Panel meeting support. Also includes guidance on pre-IDE meeting strategy, support with presentations and as your liaison with FDA through the pre-IDE review process.

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enemconsulting.com enemconsulting.com

:: ENEM CONSULTING ::

ENEM Consulting LLC is a life sciences regulatory consulting company providing clients with comprehensive regulatory, quality and clinical services. Seamless blending of strategy with execution. Regulatory and Project Planning. FDA Communication and Submission Management. Clinical Planning, Strategy and Operations.

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