Friday, 30 July 2010
Regulatory submissions
We will help you prepare your regulatory submissions and sending these to the regulatory agencies. We will then proactively follow-up the submissions identifying and responding to questions and issues as they arise to facilitate the approval process. Some of the regulatory submissions we can help you with are listed below.
- Clinical trials applications (CTAs) - We will help you prepare the investigational medicinal product dossier (IMPD) and submit this to the national authorities, dealing with any questions that may arise from the assessment as required.
- Marketing authorisation applications (MAAs) - We will help you prepare your marketing authorisation applications in accordance with requirements of the CTD format. We can also help you with preparing the submissions in electronic form (eCTD) and transmitting these to the relevant regulatory agencies. Submission processes include Centralised, Decentralised (DCP), Mutual Recognition (MRP) as well as national applications. Although our primary focus is on submissions to European regulatory agencies, we can also help you with submissions to other agencies outside Europe.
- Orphan medicinal products (OMPs) - We will help you prepare and submit applications to the EMEA for orphan medicinal product status.
If you would like help with any regulatory submissions, or would like further information, please contact us.