Garden Grove, CA—Alkemist Labs and REJIMUS have announced a collaboration to offer comprehensive GMP compliance solutions to clients, according to a press release.
Alkemist Labs, a contract testing lab, and REJIMUS, a regulatory management solutions provider, offer clients highly organized, comprehensive quality and compliance support for medium to large-scale product development efforts, quality control and regulatory strategy planning, specifications development, quality system optimization, and analytical/litigation investigations, according to the press release. Both companies will have key personnel and resources dedicated to helping fast-track the development and submission of more first-time successful GRAS and NDI notifications, compared to industry averages.
Elan Sudberg, CEO of Alkemist, said in the release, “FDA has said time and time again that the industry is not making as much progress with GMP compliance as it should, and that identity testing and documentation are consistent failings. Many GRAS and NDI applications fail because they are inadequately prepared, wasting time and money. We believe that making it easier for companies to work with an expert team can help improve that record.”
Brandon Griffin, CEO of REJIMUS, said, “Often there is a huge disconnect between what a finished product or ingredient specification calls for and the corresponding label, and this leaves the brand owner holding the regulatory liability bag so to speak, if not outright struggling to figure out what is the right thing in order to mitigate possible legal or regulatory actions. We can prevent this vulnerability from occurring in the first place, which is a much more efficient use of resources.”