There continues to be a big need for new molecules of the medical importance of controlled substances that specifically address medical indications and conditions. Rigorous regulations around the development and manufacturing of controlled substances make it very challenging which has led many companies to outsource to a contract development and manufacturing organization (CDMO) that has the expertise and regulatory support.
Due to the opioid pandemic, controlled substances were highly pilloried, and not considered good practice. The negative perception of controlled substances led to studies being abandoned but in recent years the landscape has changed. The industry is now exploring the therapeutic uses of controlled substances and the pharmaceutical industry is encouraging new approaches to meet the demand for new treatments for several indications.
Advantages of Outsourcing to Mikart
At Mikart, we have specific compliance and safety measures in place. We are DEA approved to develop and manufacture schedule 1 controlled substances in our facilities. At Mikart, we continue to make investments in our facilities to serve as a comprehensive partner to our clients in the CDMO space.
- Mikart has a sound Compliance Management System (CMS) and Quality Risk Management (QRM) solutions to ensure that specific processes are being properly handled, as well as to provide a well-documented record of compliance. In 2018, Mikart underwent a digital transformation initiative that included a fresh look at quality management system needs. The goals included modernizing quality processes to meet and exceed current FDA and cGMP standards to better serve the current and future needs of their expanding client base. Mikart looked to technology to address was to shift quality from being paper-based to digital.
- Mikart has a good relationship with the DEA and FDA. Mikart understands the specific changes to the laws and continually stays up to speed on changing guidance and demonstrable best practices.
- Mikart has a diligent screening process to successfully source high-quality raw materials.
- Mikart has established comprehensive controls adhering to cGMP protocols when manufacturing, handling, and storing products. These processes are practiced throughout our organization and to our employees.
Mikart is a Contract Development and Manufacturing Organization that specializes in a variety of services from early phase development project work to commercial manufacturing. Our commercial manufacturing capabilities include liquids, tablets, capsules, and controlled substances. Also, our packaging capabilities are 2023 compliant with the Drug Supply Chain Security Act (DSCSA) and conveniently located in Atlanta, GA.
Given our large manufacturing facility’s capabilities, Mikart can provide you with the expertise of a large CDMO, but with the flexibility and agility of a smaller organization. We provide you and your organization the individualized focus and exceptional results that your product deserves.