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IWACONSULTING.DK

IWA Consulting - For quality, safety, and efficacy

The IWA Consulting Team is a dedicated group of regulatory affairs specialists providing in-depth knowledge, and expertise.

http://www.iwaconsulting.dk/

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IWA Consulting - For quality, safety, and efficacy | iwaconsulting.dk Reviews
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The IWA Consulting Team is a dedicated group of regulatory affairs specialists providing in-depth knowledge, and expertise.
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1 services
2 global ectd submissions
3 regulatory intelligence
4 regulatory development
5 regulatory affairs
6 medical affairs
7 medical device
8 quality assurance
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IWA Consulting - For quality, safety, and efficacy | iwaconsulting.dk Reviews

https://iwaconsulting.dk

The IWA Consulting Team is a dedicated group of regulatory affairs specialists providing in-depth knowledge, and expertise.

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1

Global eCTD Submissions | IWA Consulting

http://iwaconsulting.dk/services/global-ectd-submissions

R&M Development Team. Medical Device & QA Team. Have you ever considered submitting your registration file as a global eCTD with the EMA and FDA, simultaneously? The IWA Consulting Team specializes in global eCTD submissions. We have a proven track record on global eCTD submissions taking place five months after Last Patient Last Visit. Just how do we manage to do that? Knowing our line of work and executing with experience enables us to navigate past pitfalls and through shortcuts. Phone: 45 56 66 04 90.

2

Teams at IWA Consulting | IWA Consulting

http://iwaconsulting.dk/teams

R&M Development Team. Medical Device & QA Team. The IWA Consulting Team provides expert support on all regulatory issues, globally. Whether operating in Regulatory and Medical Delvelopment. Regulatory Affairs Quality,. Or in Medical Device, QA and eCTD. Any member of our team works dedicated to the task and knows the sense of urgency on getting the job done and meeting the deadlines. For more information on our services click here. R&M Development Team. Medical Device & QA Team. Phone: 45 56 66 04 90.

3

QA Standards | IWA Consulting

http://iwaconsulting.dk/qa-standards

R&M Development Team. Medical Device & QA Team. The IWA Consulting Team has developed and implemented a Quality Management System based on the ISO 9001 quality standard and on GxP guidelines. Through this we are able to guarantee our clients a consistent high level of quality covering all aspects of our services. Since September 2009 our Quality Management System has been DS/EN ISO 9001 certified. All employees are trained in the Quality Management System and with their areas of responsibility.

4

Regulatory Development | IWA Consulting

http://iwaconsulting.dk/services/regulatory-development

R&M Development Team. Medical Device & QA Team. Knowing where your are going will make the journey shorter and less time consuming. The IWA Consulting Team can assist you on developing your regulatory strategies. We have significant experience in preparing for and assisting during scientific advice with international authorities. Furthermore we can assist you on electronic clinical trial applications in Europe (CTAs/eCTAs) and in the US (INDs/eINDs), assisting in preparation of Investigator s Brochures.

5

Quality Assurance | IWA Consulting

http://iwaconsulting.dk/services/quality-assurance

R&M Development Team. Medical Device & QA Team. At IWA Consulting Team we focus on maintaining the ultimate level of quality standards.This philosophy we apply to our employees and we take it with us when working on assignments for our clients. For more information about quality assurance services, please contact our Medical Device and QA Team. R&M Development Team. Medical Device & QA Team. Medical Device & QA Team. Phone: 45 56 66 04 90. Fax: 45 56 66 04 91.

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