Regulatory Affairs Page Header

Lifecycle Management.

Protecting your investment.

After your product receives approval, multiple changes can occur which may or may not have an impact on its registered details. Our expert consultants can advise you if you need to act to remain compliant and within the change management process identify the change impact, the change classification, and advise on submission strategy and support documentation.

Failure to do this puts your marketing authorization investment at risk.

Through our deep understanding and expertise, and the use of extensive regulatory intelligence we can help you protect your investment by ensuring your products are compliant and on the market throughout their life cycle.

Variations and National phase.

Variations can always be required following various exercises like a gap analysis for example, or changes in:

  • Raw materials specification and suppliers/manufacturers
  • Manufacturing site
  • Manufacturing process
  • Finish product specifications
  • Shelf life
  • Legislation
  • Product safety profile, etc.

Our team of experts are focused on maintain the compliance of your product, and can support you with predicting changes, understanding change complexity, and designing the best regulatory strategy for submissions and change implementation, all geared to ensure your product remains available on the market uninterrupted.

Variations could be under European procedures, where we will act immediately after RMS approval to ensure smooth implementation, or during national procedures, and in either case we are here to fully support you every step of the way with extensive regulatory intelligence and local representation in your countries of interest.

We closely monitor all submissions and approvals and follow-up quickly with authorities. Our aim is to manage your change implementation while ensuring no interruption to product supply or out of stock situations.

Market Authorization Transfer (MAT) support.

Changing Marketing Authorization Holder (MAH) is a key part of your commercial strategy and our consultants have extensive experience with the considerations and processes involved.
We can identify suitable partners to hold your MA in a particular territory, or we can support a transfer of your portfolio between companies.

Our experts will carefully plan your transfer process by engaging an interdepartmental team to assess and manage your supply and marketing needs. Drawing on our extensive regulatory intelligence capabilities, we will identify all the activities and timelines associated with your MAT, ensuring there is no disruption to supply and the immediate introduction your product on the market.

We’ve packaged our tips for tackling the challenges of Marketing Authorization Transfer in Europe, in this easy to understand Arriello guide.

Download our MAT guide…

Reference Member State (RMS) transfer.

As part of your product life-cycle market strategy you may need to switch to another RMS. No problem, we can guide you and provide a full support service to make switching easy.