A regulatory consultancy you can rely on
The management of a European dossier submission process can become complex with translations into official EU languages, national administrative requirements and authority fee payments. TPRAC can manage the complete dossier submission process via all required routes (CP, MRP, DCP, NP) and can act as point of contact with the National Competent Authorities, managing the regulatory procedure on your behalf, allowing you to use your time resources elsewhere.
TPRAC’s team can organise all pre-submission actions, prepare responses to authority questions during the procedure itself (LoQ), liaise with EU authorities to ensure that assessment timelines are rigidly adhered to and complete all national requirements (such as linguistic review and checking compliance for mock-ups of the labelling and packaging) to ensure your product gets to market on time. Having wide-ranging language capabilities (please refer to our Contact Page) can also be an asset to your company. You don’t need to be a linguist to benefit from our skills either: we find that communicating with the regulators is greatly facilitated by speaking their language.
Our effective project organisation, coupled with excellent communication, means that our clients are kept fully informed of their projects’ progress, and puts them in control of their submissions at all times.
Strategy for the EU, and for Global Markets
A clear understanding of the merits and limitations of all the regulatory options available allows TPRAC to identify the best regulatory strategy for your product, which meets with your budget and available resources. An appreciation of key differences in the authorization 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, TPRAC is an ideal business partner. As part of the 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 authorization’), the most favorable SPC and labelling criteria, optimal distribution categories, etc.