With cost containment a priority and supply chain disruptions a now-persistent threat, pharmaceutical manufacturers are under pressure. The race to outsource development and manufacturing of life-saving drugs to trusted service providers is accelerating.
For preclinical-through-Phase III development – and especially for those firms who are small or virtual pharma organizations – choosing the right contract development and manufacturing partner can make or break a project.
Access to experienced regulatory services throughout the project is often a must, given the often limited internal resources of small and midsized companies. Regulatory expertise tends to be a commonly overlooked aspect of CDMO services. Often it’s a case in which bio/pharmaceutical companies are just not aware how CDMO regulatory management can best complement their own internal know-how.
In an earlier post (Why a CDMO Might Be the Best Place to Find Regulatory Support), we discussed the one-stop-shop CDMO model, and how regulatory support services are becoming more common among full-service CDMOs.
LGM is no exception. Our Regulatory Management group designs regulatory strategies and pathways that can smooth the path to approval – whether new drug applications (NDA), abbreviated new drug applications (ANDA) or other pathways such as 505(b)(2).
Yet regulatory professionals have a wider mandate than simply overseeing submissions and compliance – or at least they should. They play a vital role from the earliest stages of a compound’s development, providing legal and technical feedback that helps R&D teams avoid obstacles during product development – conserving a drug sponsor’s time, resources and money.
Leveraging CDMO Regulatory Expertise
Many CDMOs provide regulatory guidance across the lifecycle, but it is uncommon for the Research & Development and Regulatory groups to work together on an ongoing basis.
One reason for this is siloing – the expectation that projects move in and out of various departments at different stages of completion. For instance, R&D will hand off to process development and Regulatory and Quality will be brought in as needed. Eventually, the project will shift to manufacturing – whether in-house or at a CDMO. In a siloed model, these groups do interact – just not on a continuous, ongoing basis.
Why Integrate R&D and Regulatory?
The challenge of siloed teams “dipping” in and out of projects is the loss of collective project knowledge. The R&D team working on the project today needs access to the regulatory team’s insights to improve their own decision-making.
Integrating these two departments allows the data, findings and insights accumulated by the Regulatory and R&D functions to be shared between them. In some cases, this enables innovation but in other cases, it avoids costly or time-consuming missteps. Knowledge is power.
At LGM, the R&D Group works out of the same facility as our in-house Regulatory Group. Both departments report to the same leader, the Sr. VP of R&D and Regulatory Submissions. This facilitates close communication and interaction between the R&D and Regulatory teams. These functions aren’t outsourced or structured as a separate group located in different facilities – or even on different continents. The team performing development work, works side-by-side with Regulatory to help guide the R&D strategy and create the regulatory submission.
Instead of periodic knowledge transfers between numerous groups, integration creates a real-time information stream. Stakeholders can quickly react to feedback from other specialties. Advice from the regulatory team, for example, can drive changes in research or process development.
Close interaction among teams enhances the ability to quickly react to these necessary changes. By reviewing the scientific data the R&D team is generating, Regulatory input can impact process design to ensure continued compliance at future stages of development.
What’s the benefit of structuring things this way? Here are the top 3 reasons why this model has been so successful for LGM Pharma and its clients:
Less project confusion & more innovation
Insights gathered by the Regulatory Affairs and Research & Development functions are easily accessed between teams to enable innovation, reduce errors, take advantage of pharmaceutical trends and create a competitive edge in drug development.- Increased regulatory submission accuracy
The unique integration of regulatory management with product development delivers more thorough filing submissions which reduce regulator questions and regulatory delays. - Accelerated projects
Better sharing means teams have access to the right information, exactly when they need it. Decision-making can occur quickly, reducing project delays and improving speed-to-market.
How LGM Pharma Regulatory Services Work
The close cooperation between our R&D and Regulatory Groups is the result of our reinvention of our internal structure, built around Quality by Design (QbD) concepts. As a framework for successful projects, we use a stage gate system. Information and documentation is shared in real-time across both teams.
When considering a CDMO for your next NDA, ANDA, 505(b)(2), generic or biosimilar project, you need confidence that your development, regulatory and commercialization strategies are aligned and working as one. Learn how LGM Pharma can provide a detailed roadmap for drug commercialization success – from project initiation to post-approval commercial manufacturing.
If you’d like to find out how LGM’s integrated Regulatory and R&D Groups can help accelerate and advance your next pre-clinical-through-Phase III development project, let’s chat!