We perform our tasks based on our long-term regulatory experience, in-depth knowledge, and expertise.

The IWA Consulting Team is a dedicated group of regulatory science specialists providing expert services to a range of international private and public clients. We perform our tasks based on our long-term regulatory experience, in-depth knowledge, and expertise.

We assist biotech, pharma, and medical device companies in achieving their major regulatory milestones, knowing and thoroughly understanding the sense of urgency that applies to this business area. Regulatory science – in every aspect of the discipline – is our core competence.

who we are

IWA Consulting – For quality, safety, and efficacy

The IWA Consulting Team is a dedicated group of highly experienced regulatory and medical science 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 certification.

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.

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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 science 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.

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we specialise in:

Regulatory Development

By combining strategic, scientific and operational expertise, we ensure successful execution of regulatory submissions throughout the development phase up until and including the registration phase thereby supporting our clients’ key business goals.

Regulatory Science 

The IWA Consulting Team offer regulatory science services in EU, US, CA and CH.

Market access

Have you considered how you will market your product and what it takes? The IWA Consulting Team provide market access services in support of launch strategies, marketing material, national texts, catalogue texts, pricing, and reimbursement.

Our services

Medical science

Do you need medical monitoring expertise? The IWA Consulting Team provides medical science services within pharmacovigilance and medical information.

Medical Device

The IWA Consulting Team can assist your organization in setting up appropriate quality systems, classification evaluations, and Conformity Assessment Procedures to select the appropriate route for CE marking.

Global eCTD Submissions and Document Management

The IWA Consulting Team has more than 15 years of experience in eCTD compiling, so whether you are facing initial eCTD submission or document management we have solid expertise to advise and assist you all the way through the eCTD processes ensuring compliant eCTD dossier and meeting submission deadlines.

Our services

Doing things differently

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.

Last published:

  • Switzerland – The Authorisation of human medicinal products under Article 13
  • How to overcome the regulatory challenge due to BREXIT
  • Implementation of Medical Device Regulation MDR 2017/745 postponed – so what’s next?
  • Health Canada implementation of eCTD for clinical trial regulatory activities

Our articles 

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. We know where regulatory files are mutually recognised and have successfully submitted. In the US and in Europe following only five months after Last Patient Last Visit. Our line of working 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 right from the start.

Upcoming webinar at Pharmakon:

How to obtain successful market access for a pharmaceutical product - Monday 16th November 2020 from 17.00 - 18.30– sign up here 

IWA Consulting ApS
Ølbycenter 7,1
DK-4600 Køge

Phone: +45 56 66 04 90
Fax: +45 56 66 04 91

E-mail: info@iwaconsulting.dk