The main goal for any drug company is achieving a speedy path to market. While many obstacles threaten that goal, the regulatory process is one of the most challenging hurdles you’ll face.
The regulatory submission process is highly complex, and when you factor in different regulatory agencies as well as multiple pathway options, regulatory support is not a one-size-fits-all mechanism. The process is often time-consuming and expensive, especially if something goes wrong or needs resubmission.
How can pharmaceutical companies with limited regulatory experience avoid costly mistakes? The quick answer is to partner with a CDMO that offers regulatory and submission support in addition to manufacturing. This article from Contract Pharma (Benefits of the One-Stop-Shop CDMO) explains it best:
“[O]utside expertise is a good approach for improving the success rate and maintaining product and process knowledge across the entire value chain. For many of these companies, reducing the number of service providers is also the desired approach as it reduces business complexity and also offers benefits over the long-term.”
Is a One-Stop-Shop for Manufacturing and Regulatory Support Possible?
When you think of a CDMO you may not necessarily think ‘regulatory support,’ but it is becoming more common among full-service CDMOs. Most now offer this service as part of a one-stop-shop model, much as we do at LGM Pharma.
When a CDMO provides support from R&D through commercialization, including regulatory and submission services, this end-to-end outsourcing is known as the “virtually-outsourced” model. It typically caters to clients with limited reach and resources. When a drug company can use one partner across the full span of services, it can preserve your valuable resources.
“Relationships in the virtually-outsourced model focus on guiding the client through the development and commercialization process. In many cases these clients do not have the resources to maintain subject-matter experts and therefore rely heavily on their CMO/CDMO partner for recommendations and insights to reach the finish line.”
(Read Expanding CMO/CDMO Roles at Contract Pharma)
It makes sense to involve your CDMO in the submission process, given how deeply involved they are in developing the drug. The CDMO has the scientific knowledge of the product and the process – in many cases from the earliest stages of development – which means it can provide the most accurate information during documentation. Not only that, but the CDMO knows its equipment and facility best, and likely already has experience with similar – if not identical – processes.
Having all this background information centralized and easily-accessible makes the submission process much more seamless, especially in the CMC sections. Your filing will move much faster when the filer is already acquainted with the different components of the process and the specific project.
CDMOs Offer the Advantage of Experience
Since CDMOs work with multiple clients, they have the advantage of experience. For example, at LGM Pharma we have handled all types of submissions—ANDAs with and without clinical data, with CBE and PAS supplement submissions— so we have a broad understanding of the regulatory process. This experience benefits our clients, as we can impart our knowledge from previous work into current projects. We can also use our experiences to improve our efficiency and incorporate new procedures into our strategy.
Ensuring we remain up-to-date with our procedures is critical since regulations are constantly evolving. In fact, being able to keep up with the ever-changing guidance documents and regulations happens to be one of the biggest challenges for clients – especially for smaller or virtual pharma companies, or those with limited pipelines.
Our clients rely on us for guidance. We continually monitor regulatory changes and keep our finger on the pulse of what the FDA expects from NDAs, ANDAs, supplements and amendments.
Regulatory submission, of course, is just the first step. The next challenge involves the need for constant communication. Companies tend to struggle with the amount of communication that must occur, leading them to fall short in fulfilling specific requirements.
This issue is significant enough that most end-to-end CDMOs (including LGM) have implemented a streamlined approach to managing interactions with the FDA.
The Regulatory Process is Collaborative
While a CDMO may take the lead in navigating the regulatory pathway, the process is inherently collaborative. The pharma company should always be in lockstep with the CDMO. No two projects are the same, so you need to feel like your unique needs will be met. For instance, we have adopted a model based on a consultative approach. We’ve found that clearly defining roles and responsibilities ahead of time, and clearly communicating over the course of the project, helps avoid missteps along the way.
As a CDMO, we may have in-depth knowledge of process development and drug product documentation, but ultimately you know the project best. So how does a drug company select the right CDMO when it comes to regulatory experience? Outsourced Pharma’s article Are you Taking Full Advantage of Your CDMO’s Regulatory Expertise? explains:
“Drug delivery and drug products exist in a heavily regulated environment, so it stands to reason that all CDMOs should have some knowledge in that area, and that expertise can be useful to pharma partners. The key differentiator between CDMOs, in this respect, is regulatory experience — both the depth of that experience and the variety, be it working with different regulatory bodies or different product types.”
LGM Pharma’s Diverse Team of Experts
Like many CDMOs, we have found value in building a team of experts with diverse regulatory experience. With a cross-functional team at the helm, a CDMO can offer your company a customized experience. Our team’s breadth of expertise has enabled us to support 120+ drug development programs pursuing the 505(b)(2) pathway in just about every therapeutic category and at every stage from pre-clinical to commercial.