Product Lifecycle Management
The purpose of our Product Lifecycle Management service is to ensure the regulatory compliance of your product throughout its lifetime. As regulations and circumstances change, we can help mediate and manage this, to reduce the risk to your product.
Product lifecycle management can be defined as the process of managing the entire lifecycle of a product all the way from its conception, through design and manufacture, to service and disposal.
Medicines that have been put on the market will change over time and this process must be managed as it moves through its successive stages. The main aims of Product Lifecycle Management are to reduce time to market, reduce costs, improve quality and optimise processes.
Attention to the product lifecycle management is an important component of any regulatory submission strategy. Not only is this process used to keep the medicine dossier compliant and up to date, but it’s also the most efficient way to submit document changes and ensure the health authority has quick access to all the most current documents and related information for an application in one place.
We understand the lifecycle management “best practices” that help to streamline the submission process, avoid future rework and reduce confusion caused by duplicate documents.
Product lifecycle management is applicable to all types of licencing; National, Mutual Recognition, Decentralised and Centralised Procedures. With our extensive local knowledge, both in-house and part of the Regulanet network, we can provide support for all European markets for any regulatory lifecycle activities.
JensonR+ can support you with your regulatory needs from development through to post-authorisation.
Our team can define the best regulatory strategy to make sure you application is right first time, with the least amount of agency fees, correct application and eCTD format, and prompt submission to the authorities.
See our Regulatory Strategy, Dossier Module Writing, eCTD publishing and Regulatory Submissions services page for more information about how we can help support all the different aspects of product lifecycle management.