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IWA Consulting ApS

Who we are

The IWA Consulting Team is a dedicated group of highly experienced regulatory and medical affairs experts and specialists providing services to a wide range of international private and public clients.

We have significant experience in preparation of CTAs/INDs and MAAs/NDAs and life cycle management for pharmaceutical products and do also cover a wide experience within Medical Device.

Our experts have specialised in the preparation and assessment of a common quality, non-clinical and clinical documentation for global submissions. We continuously operate with the Common Technical Document dossier in a fully integrated eCTD solution.

How we work

The IWA Consulting Team is committed to stand by our clients from development to launch and life cycle management of pharmaceuticals and medical devices. 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.

We have long term regulatory and medical affairs experience and in-depth knowledge. Furthermore, we have the courage to give honest advice.

Knowing where you are going will make the journey shorter and less time consuming. We trust that doing things right from start is the fastest and most efficient route to reach the goal.

What we offer

Specifically, we specialise in:

  • Regulatory Intelligence
  • Regulatory Development
  • Regulatory Affairs
  • Medical Affairs
  • Medical Device
  • Global eCTD Submissions
  • Document Management

Visit our website and learn more about our services www.iwaconsulting.dk/services.

Doing things differently

Do you want to apply for registration in the US and EU, simultaneously?

The IWA Consulting Team has a proven track record on global eCTD submissions in the US and in Europe following only five months after Last Patient Last Visit. Knowing our line of work and executing with experience enables us to navigate past pitfalls and through shortcuts.

We will see your plan through to success on a global eCTD submission with access to the electronic submission gateways.

When you start – start right; The IWA Consulting Team helps you to focus your development projects from the start.

Maintaining the highest standard

Since September 2009 our Quality Management System has been DS/EN ISO 9001 certified.

We maintain a consistent high level of quality covering all aspects of our services by fully training all staff members to ISO 9001 standards.

Get in touch with us!

Visit us

IWA Consulting ApS
Ølbycenter 7,1
DK-4600 Køge

Send us mail

Our published articles

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IWA Consulting ApS

IWA Consulting ApS

Who we are

The IWA Consulting Team is a dedicated group of highly experienced regulatory and medical affairs experts and specialists providing services to a wide range of international private and public clients.

We have significant experience in preparation of CTAs/INDs and MAAs/NDAs and life cycle management for pharmaceutical products and do also cover a wide experience within Medical Device.

Our experts have specialised in the preparation and assessment of a common quality, non-clinical and clinical documentation for global submissions. We continuously operate with the Common Technical Document dossier in a fully integrated eCTD solution.

How we work

The IWA Consulting Team is committed to stand by our clients from development to launch and life cycle management of pharmaceuticals and medical devices. 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.

We have long term regulatory and medical affairs experience and in-depth knowledge. Furthermore, we have the courage to give honest advice.

Knowing where you are going will make the journey shorter and less time consuming. We trust that doing things right from start is the fastest and most efficient route to reach the goal.

What we offer

Specifically, we specialise in:

  • Regulatory Intelligence
  • Regulatory Development
  • Regulatory Affairs
  • Medical Affairs
  • Medical Device
  • Global eCTD Submissions
  • Document Management

Visit our website and learn more about our services www.iwaconsulting.dk/services.

Doing things differently

Do you want to apply for registration in the US and EU, simultaneously?

The IWA Consulting Team has a proven track record on global eCTD submissions in the US and in Europe following only five months after Last Patient Last Visit. Knowing our line of work and executing with experience enables us to navigate past pitfalls and through shortcuts.

We will see your plan through to success on a global eCTD submission with access to the electronic submission gateways.

When you start – start right; The IWA Consulting Team helps you to focus your development projects from the start.

Maintaining the highest standard

Since September 2009 our Quality Management System has been DS/EN ISO 9001 certified.

We maintain a consistent high level of quality covering all aspects of our services by fully training all staff members to ISO 9001 standards.

Get in touch with us!

Visit us

IWA Consulting ApS
Ølbycenter 7,1
DK-4600 Køge

Send us mail

Our published articles

No items found.
Date
Title
Category
No articles found.