Regulatory intelligence & strategic planning

Development and marketing strategies

Cyton understands the important roles regulatory intelligence and strategic planning play in effective and swift authorisation of veterinary medicines and other animal health products.  Whatever stage your project is at, we can add value through expert advice on product development strategy - through the authorisation process, and beyond.

Business planning and horizon scanning

Planning is essential to any business strategy, and in-depth knowledge of the regulatory environment in which your product will be marketed is crucial to its success.  The requirements and regulations across the EU and nationally within each Member State are continually changing and evolving, but through our many years of interaction with the Competent Authorities we have built strong, positive working relationships. Furthermore, as a matter of course our personnel seek out the relevant regulatory news and official updates, so that we always keep abreast of the current situation and remain alert to any forthcoming changes on the horizon.

You can benefit from these activities at no cost, by following Cyton's various online and social media regulatory affairs update services:

Strategy for the EU, and for Global Markets

A clear understanding of the merits and limitations of all the regulatory options available allows Cyton to identify the best regulatory strategy for your product, which meets with your budget and available resources.  An appreciation of key differences in the authorisation processes and data requirements between the main global markets allows us to highlight to our clients where they may encounter problems and how best to avoid them; understanding where the regulatory differences can work to the advantage of our clients is also one of our strengths.  If you have global ambitions for your product, Cyton is an ideal business partner.  As part of the knoell group, we have animal health capability in many key markets (see International Services), and through strategic collaboration with trusted partners in other regions we can support your product development and launch at a multi-national scale.

Apart from strategic planning for the consideration of cost, time and the overcoming of regulatory hurdles, the major benefit from our strategic support is the enhancement of marketability for your product compared to its competitors. Increased marketability can be achieved through: choice of viable reference products (for generics, considering the notion of a ‘global marketing authorisation’), the most favourable SPC and labelling criteria, optimal distribution categories, etc.

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