- Regulatory Affairs
- Medical Information
- Strategic Development
- A to Z of Services
Before submitting a marketing authorisation application in the EU, there are a number of key processes to undertake which will influence the requirements and subsequent direction your new product takes. Most importantly, completion of these obligations will help ensure successful approval by the regulators.
How can we help?
We pride ourselves in our ability to support clients through the pre-authorisation phase. Our experts can help optimise your development programme to ensure you are fully aware of all of the requirements you need for a positive regulatory outcome.
There are attractive incentives for Small and Medium-sized Enterprises (SMEs) and for companies developing medicines for orphan indications. We can advise you on the likelihood of qualification as well as submit on your behalf to gain the desired status and access to the incentives.
For new medicines, a Paediatric Investigational Plan (PIP) or waiver needs to be submitted early on. The need to consider all groups in the paediatric population means this can be an intense undertaking at a busy time, when there also remains a lot to be learnt in the adult population. However, the rewards can be substantial, with an additional six months of patent protection. For established active substances, a potential 10 years of data exclusivity in the paediatric indication is designed to entice generic companies to consider paediatric development.
Scientific advice is encouraged and with the availability of both national and centralised advice, the best tactical route at a given stage of development needs to be decided. With its procedural expertise, ability to identify and crystallise the scientific issues and considerable experience in preparation of the supporting documentation and presentation of the questions and company position, we will ensure that you get the most out of scientific advice.
The EU legislation need not be daunting and with the right support can provide opportunities and competitive advantage. Our experienced team can guide you on the regulatory strategy.
For a more detailed discussion on how we can help you, contact us on +44 (0)1628 530554 or email us via our contact form.REQUEST MORE INFORMATION