Regulatory Submission Packages

A regulatory submission is 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 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 you are submitting to.

regulatory submission

We are experienced in a number of different regulatory submissions for human medicines in the EU and UK:

  • Clinical Trial Authorisations (CTAs)

  • Marketing Authorisation Applications (MAAs)

  • Extension applications

  • Variations (Type IA, IB, II)

  • Article 61(3) notifications

  • BROMI notifications

  • Renewals

  • Repeat Use Procedure

  • Scientific Advice

  • Marketing Authorisation Transfers (MATs)

  • Urgent Safety Restrictions

  • Periodic Safety Update Report (PSUR)

  • Withdrawal of Marketing Authorisations

  • Orphan Designation application

  • Reclassifications (Switches)

Submissions can be made directly to regulatory agencies via email or national portals or CESP or via the EMA gateway for European procedures.

Whatever regulatory activity you have in mind we 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, see our eCTD publishing and dossier module writing/gap analysis services page for more information about how we can help support the technical side of the submission package.

We would like to talk to you and we will listen.

We aim to understand your objectives, your aspirations and your ultimate goals.

Janet Worrell