Integrated Regulatory Affairs Services
Strategic consulting and regulatory intelligence to operational submissions success.
After a complex and extensive registration process of either a pharmaceutical or a medical device product, regulatory institutions and agencies must come to the clear conclusion that your product is beneficial for that targeted patient population, and will definitely make a difference in their lives. To achieve this level of confidence, Eurotrials integrates several regulatory services to guide your product to an optimal regulatory path.
To gain market advantage, regulatory agencies need all the data available to make a conscious decision, which aggregates many levels of different data from different sources. The dossier of your product cannot miss any of this information. Our integrated team of medical writers, biostatisticians, regulatory consultants and health economics specialists focus on the development of a high quality dossier ready to be analysed and interpreted to achieve an optimal outcome.
- Regulatory strategy and intelligence services
- Health authority/agency consulting, advisory and liaison
- Regulatory submissions: pharmaceuticals, medical devices, orphan drugs and biologics
- Labelling services
- Clinical and nonclinical development consulting
- Regional regulatory planning: Europe & Latin America
We can help you with marketing authorizations for new drugs, biological license applications, generics and medical devices submissions. Contact us to know more about our scope of work, even if what you need is assistance with a specific project, such as an orphan drug application.