Dossier Lifecycle Maintenance
Following its acquisition of an extensive approved product portfolio from one of the top three pharmaceutical companies in the world, this medium-size pharmaceutical organization needed to find a partner capable of undertaking a comprehensive menu of lifecycle maintenance activities on its behalf.
Managing a portfolio of 70 molecules, 85 procedures and 950 Marketing Authorizations (MAs) is no small undertaking. This task was further complicated by the fact that this non-EU based pharmaceutical organization was about to take ownership of a product portfolio with European national and DCP procedure approvals.
The organization therefore wanted to source both the resources and specialist regional regulatory expertise it needed to manage this large and complex MA portfolio. Finding a trusted partner would not only relieve the company of a significant regulatory maintenance burden; it would also ensure marketing authorization renewals were kept up-to-date.
That meant finding a trusted outsourcing service partner to undertake all essential lifecycle management activities – from maintaining post-approval commitments to managing local variations, renewals and product sunsets – in a timely and cost efficient manner.
ELC Group solution
Overseeing the transfer process represented a major undertaking. ELC Group’s regulatory affairs specialists began a rigorous assessment of each individual MA, identifying opportunities for harmonizing conflicting local or regulatory procedure requirements and resolving potential stakeholder conflicts. Prior to undertaking the data transfers, ELC Group completed due diligence checks to establish regulatory status – under assessment or approved – and identify a timeline for each MA.
Next, the ELC Group team prepared a streamlined regulatory submission schedule to support an effective lifecycle management strategy. Seamless procedures were implemented to ensure the continued compliance of licensed products could be maintained against the backdrop of an ever-changing regulatory environment.
Combining lean operational processes with local regulatory expertise, ELC Group was able to undertake lifecycle maintenance activities on the entire portfolio in a highly cost-effective manner. This included initiating strategies to manage submissions, local variations, renewals and end-of-life strategies.
The ELC Group solution comprised:
- Scientific advice and innovator licensing trend and indication approval analysis
- Detailed analysis of key opinions which informed the Submission Strategy
- Selection of Applicants and the MAH
- Finalization of local requirements
- Selection of data to be included in the Marketing Authorization Application (MAA) submission management
- Extensive engagement with the relevant European Competent Authorities (CAs)
- The full transfer of all MAs was completed quickly and accurately, with a full Clinical Outcomes Assessment application completed for each one.
- Construction of an RMS, CMS and eCTD publishing schedule for each MA.
- All safety variations are documented, and name changes or Batch Release programs managed.
- Managing communications with local distributors, including approval of mock-ups.
- The preparation and management of renewal applications are completed accurately and in a timely fashion.
- Extension requests for sunset exemptions are made following an appropriate assessment.
- All Periodic Safety Update Reports (PSUR) and now written and submitted by ELC.
- Completion of detailed literature searches and ADR (Adverse Drug Reporting) submissions.