We are able to perform such service in other worldwide markets such as the United States of America, Canada, Australia, Israel and Japan.
ExperTrials’ Head of Regulatory Affairs will coordinate all our country Clinical Research Consultants (CRC) who will be responsible for Regulatory activities in their respective country. As our CRCs are locals, you can rely on their awareness of the applicable regulations in each region/country.
Our CRCs have strong experience in regulatory affairs activities related to clinical trial applications procedures for both drugs and medical devices.
We also accompany and support you in the last step and most exciting part of your drug development: the marketing authorization of your drug or medical device.
In Europe, our regulatory experts submit MAA by notifying EMA at least 7 months before the submission by following one of the procedures below:
As for all medicines, generic medicines must obtain a MA before they can be marketed.
The European Medicines Agency (EMA) assesses applications from companies to market generic medicines in the European Union (EU). A generic medicine is developed to be the same as a medicine that has already been authorized, called the reference medicine.
As FDA and EMA recommendations are to provide new methods to identify and eliminate unnecessary in vivo BE studies.
By applying biowaiver approaches whenever possible, generic companies can save a lot of resources.
A paediatric investigation plan (PIP) is a development plan intended to support the authorisation of a medicine for children. It aims to ensure that the necessary data is obtained through studies in children, when it is safe to do so.
Pharmaceutical companies are required to perform clinical studies in children before being able to apply for marketing authorization of a new medicinal product in the EU (or for a new indication, dosage form or route of administration of an authorized, patented product), unless they have agreed a waiver or a deferral with the Paediatric Committee (PDCO) of the European Medicines Agency (EMA).
A status assigned to a medicine intended for use against a rare condition. The medicine must fulfil certain criteria for designation as an orphan medicine so that it can benefit from incentives such as protection from competition once on the market.