The regulatory landscape is a complex one, and poses challenges for any company looking to commercialize a drug. Adding to the complexity is the fact that different regulatory agencies have varying requirements – some are subtly different, but these differences can also be significant. And the costs of any errors can be substantial, both in terms of time and money. Little wonder that companies often rely on their CDMO partners for assistance in navigating the regulatory process.
Getting it right from the beginning
Errors or omissions at the preclinical stage can have a huge impact later on. An experienced CDMO will understand the importance of considering regulatory requirements in the very early stages of a project, and long before any IND submissions are made. A good partner will understand the long-term goals of a project, and ensure that everything is done with the regulator in mind, even when it is still in preclinical development. Choosing a process, task or step to save time and money in the very early stages, for example, would be counterproductive if it has to be removed or reworked later to comply with the regulatory requirements of later stages. The CDMO partner should also know exactly what needs to be done at each stage of development, and what could – or should – be done later on.
A pharma/biotech company would also be wise to choose a partner with extensive experience in the different regulatory frameworks of any region where they hope to commercialize their medicine. And if the product is likely to be a controlled substance, gaining the additional approval from agencies such as the US Drug Enforcement Agency (DEA) would also benefit from expert help.
Managing region-specific requirements
Even without the added complication of controlled substance approvals, an in-depth understanding of the drug approval process of agencies such as the US Food & Drug Administration (FDA) or the European Medicines Agency (EMA) is critical. There is no substitute for experience and knowledge about regulatory compliance in reducing risk and speeding up a product’s time to market. All molecules on the pathway to approval require the same attention to detail, the same compliance with Chemistry Manufacturing Controls (CMC) guidance, and the same care with documentation.
The critical role of CMC compliance
The CMC guidance from FDA, for example, provides comprehensive instructions to pharma companies. CMC helps confirm that the manufacturing processes, ingredients and quality control measures used in the production of active pharmaceutical ingredients are safe, effective and consistent. By closely following these guidelines, pharma companies – and the patients their medicines will treat – can be assured that the products will meet FDA regulatory standards. Yes, adherence to cGMP is not necessary before the molecule enters the clinic. But laying the groundwork in preclinical will greatly enhance the likelihood of a fast, efficient transit through the pipeline.
Keeping pace with regulatory change
An experienced CDMO will know exactly which policies and procedures must be adhered to at each stage, giving pharma company customers a head start in ensuring their entire development process will be in compliance. They will also have insight into agencies’ current thinking. FDA, for example, has taken a particular interest in nitrosamines and other potential genotoxic impurities in recent years, while previously more of their focus was on elemental impurities, particularly heavy metals. These insights feed back into the earliest stages of development – amending processes to ensure these problematic substances are not present, and using analytical methods to ensure any residual impurities remain within the regulator’s strict limits. This should help avoid delays and costly process modifications later on.
From development to post-approval support
An effective CDMO partner will be with its customers all the way through the development process, all the way from the first meeting with the FDA about a project through to post-approval support. Commercial approval is not the end of the road, though – post-approval sNDAs may be required, labelling updates will need to be managed, safety reports submitted and, of course, compliance with regulatory commitments will need to be maintained throughout the drug’s lifecycle.
A partner for the full regulatory journey
The Siegfried Acceleration Hub Athens is proud of its extensive expertise in this complex area. We provide our customers with the support services they need to meet all regulatory requirements, including any additional layers of compliance if it is a controlled substance, and planning ahead right at the earliest stages of preclinical development. We can deliver strategic guidance, help define the regulatory strategy, interpret guidelines, and assist in preparing for and planning IND/IMPD and NDA/MAA submissions. Our team can even author all the CMC documentation required and support customers with their regulatory strategy. And we are also proud that our customers find our skills and experience in navigating the complex regulatory environment invaluable, even when a project is still in preclinical development.
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