Understanding the FDA Process to Commercialize Drugs

Understanding the FDA Process to Commercialize Drugs

When it comes to commercializing drugs, navigating the regulatory landscape can be complex and challenging. At Purisys, we have a proven ability to help organizations bring controlled and non-controlled substances to market through:

  • Foresight – We know the long-term goals of a project, and don’t incorporate something early on in the project that will have to be removed later.
  • Experience – We work with agencies all around the world and know all of their requirements.
  • Understanding – We are experts in every phase of a project, and what tasks are appropriate for each phase, and don’t do things that we don’t need to do.

We have decades of experience helping organizations obtain approvals from the Drug Enforcement Administration (DEA) for controlled substances. With an in-depth understanding of the U.S. Food & Drug Administration’s (FDA) drug approval process, we also leverage our experience and regulatory compliance knowledge to reduce risk and speed up product to market for customers who develop non-controlled substances.

The reality is that when you are working with non-controlled substances and you strip out the DEA, a molecule is a molecule, and the basic governing documentation process for non-controlled molecules is the same as it is for controlled molecules. We have worked with the FDA extensively and have first-hand experience and knowledge about what they are looking for through their Chemistry Manufacturing Controls (CMC) Guidance.

The FDA’s CMC documents provide guidance and instructions to pharmaceutical companies that helps confirm that the manufacturing processes, ingredients, and quality control measures used in the production of small molecule active pharmaceutical ingredients (API) and other medications are safe, effective and consistent. By following these guidelines, we ensure that we and our customers are meeting the regulatory standards set by the FDA.

Through the experience we have with the FDA, we know which policies and procedures we are required to adhere to, so we help our customers start development in a position of compliance. For example, through our recent work with the FDA, we found that they are increasingly focused on the effects of genotoxic impurities, while a few years ago more of their focus was on elemental impurities, like heavy metals. To ensure compliance, we started looking for and removing these materials early in the development process, and if they were not being removed effectively, we developed analytical methods to continuously monitor a given compound in order to ensure compliance with FDA requirements. Taking these proactive steps helps our customers avoid delays and costly modifications later on in the process.

Investigational New Drug (IND) and New Drug Application (NDA) support

We are with our customers all the way through the development process, from the first meeting with the FDA through post-approval support, submitting post-approval supplements to the FDA, managing labeling updates, submitting safety reports and maintaining compliance with regulatory commitments. We provide our customers the CMC regulatory support services they need to meet FDA’s requirements to bring their non-controlled substances to market, which includes Investigational New Drug (IND) and New Drug Application (NDA) submissions. We can deliver strategic guidance, help define the regulatory strategy, interpret guidelines and assist in planning their IND and NDA submissions. Our team also writes and prepares the documentation required for the submissions.

If you are bringing a non-controlled substance to market and want to work with a CDMO that can help you navigate the complex approval process of the FDA, reach out to us today.

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