When you start – start right

Since the standardised eCTD (electronic Common Technical Document) format has become mandatory for all applications submitted to Health Authorities in the EU and the US, the possibility of delivering an almost indefinite amount of information is evident. New Marketing Authorisation applications for new compounds or drugs typically consists of between 500,000 and 1,000,000 pages; this has proved not only to be an advantage:

” The digitisation of the application format increases the importance of having a deep understanding of the field you’re working in. Since it is now possible to provide your application electronically, many people think that more information is better. This has the effect that fewer people make decisions on how the story of their product is to be told, and, consequently, are (mis-)lead to provide much more documentation than they need to. And as a result, these people risk jeopardizing presenting a precise scientific conclusion for their argument and, ultimately, their application. From our perspective, this is one of the most significant risks of being able to provide everything,” says Lillan Rejkjær, Managing Director at IWA Consulting ApS, a consultancy company which provides advise and support to both private and public companies and institutions on all aspects of Regulatory Science.

Connie Thestrup, Managing Director, adds:

”If you do not have a good strategy for how you want to provide your data to the Health Authorities you are risking getting a lot of questions back from the Health Authorities instead of a fast approval. This can be very time- and, obviously, cost consuming. It is therefore critical that you have someone working with you from early in the process to ask the right questions and provide the right guidance so that your application is clear, well documented and concise. We have taken on that role numerous times and have both the scientific and the regulatory knowledge and expertise, as well as the experience working with the Health Authorities on all types of submissions.”

Not many biotech companies or manufacturers of compounds/entities or drugs/devices have enough in-house specialised resources to manage the complex and extensive regulatory tasks which the development of medicines and medical devices requires.

” It is not only the small and mid-size enterprises (SMEs) that do not have these specialised resources employed in-house; it is also bigger companies with their own Regulatory Affairs departments in-house that sometimes ask for our assistance, advice and guidance – not least when the product calls for an application with a specific regulatory strategy”, says Lillan Rejkjær.

IWA Consulting provides assistance with all aspects and matters of regulatory science, both remotely and on-site.

UV/Vis spectrum of 60 mg/L PDC in 0.001 M HClO4 including the +/- 0.010 A acceptance criteria per wavelength (235, 257, 313, 350 nm).

Defining the goal – the approval – may be easy, but there may be lots of different ways to get there, and these may all have different requirements, costs and consequences. Therefore, the motto ’When You Start – Start Right’ is rather a way to survive than it is a smart slogan for IWA Consulting. From experience in and with the industry, the company knows that it may have serious consequences not to do your Regulatory “homework” properly, and preferably at the very beginning of the process.

” Worst case, the approval of the newly-developed medicinal product or medical device will be delayed because the Health Authority requires additional information or clarification on the documentation, which then consequently results in documents having to be updated, reviewed, and re-submitted. This is obviously an expensive and often not planned for additional task which could have been avoided or minimised with due diligence – the right regulatory guidance and proper planning,” says Connie Thestrup.

The expertise in-house at IWA Consulting covers all aspects of regulatory science from pre-approval and early development to approval and post-approval activities and Market Access.

” One of the most important things to consider is whether the product can gain access to the market at a fair price; can you demonstrate the value of the new drug/product and justify the pricing? Most companies would say ‘of course!’, but this is actually one of the more difficult and really important aspects where you may fail if you have not carefully ensured that you are creating a product with the right value for all the stakeholders,” says Lillan Rejkjær.

” Maybe our client has not carefully considered demand and pricing; is there a medical need for the product or is the product at all wanted in that specific market i.e. due to cultural constraints? It may be that the product cannot gain approval or market access in all of the European countries or in the United States as originally planned, but only in some countries, and then the development of the product may suddenly turn out to be too expensive. These are some of things we help our clients take into account – and the earlier in the process we can do that, the better”, Connie Thestrup adds.

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