Regulatory Submission Packages

Regulatory submissions are the process through which your company provides information to the regulatory authorities for review, whether this is for a new product you want to launch or for the maintenance of an existing one.

Once you have defined your regulatory strategy, the next step is building your submission package. Submission packages vary significantly, depending on the type of product, regulatory activity, and regulatory authority to whom you are submitting.

Submissions can be made directly to regulatory agencies via email or national portals or CESP or via the EMA gateway for European procedures. The regulatory team at JensonR+ is experienced in a number of different regulatory submissions for human medicines in the EU and UK including:

Regulatory Submissions

Whatever regulatory activity you have in mind, our team of experts can manage the submission for you. We can calculate the fees associated with a particular submission, so you know what the regulatory authority costs are upfront.

Our team can also make sure the right technical data is presented and the application is in the correct format.

Get in touch with us to find out more