Alkemist has developed a reputation as an expert in botanical ingredient identification, with a large library of validated voucher specimins on hand. And REJIUMS, which was recently rebranded from its previous name of Ingredient Identity, has an equally long history in scientific and regulatory consulting and GMP training.
Former informal cooperation
The companies have cooperated in a less formal way in the past, said Alkemist CEO Elan Sudberg. The new partnership recognizes the respect the two companies have built up for one another.
“I have worked with Brandon Griffin (REJIMUS CEO) for about 15 years,” Sudberg said. “We get a lot of clients that really have no idea about some of the requirements of the industry. We’ll see that they need things like a label claim review, and we’ve sent them to REJIMUS .”
“By the same token, they will go so far as to choose not to work with clients that are working with certain lower quality labs for their ID testing,” he said.
Via the collaboration, Alkemist and REJIMUS can now 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. The companies will also be able to more easiy team up to bring competencies to bear to help fast-track the development and submission of Generally Recognized as Safe (GRAS) and New Dietary Ingredient (NDI) Notifications. It’s expected that this team approach can bring more of these submissions to a successful first time conclusion compared to industry averages.
“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. And many GRAS and NDI applications fail because they are inadequately prepared, wasting time and money,” Sudberg 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,” Griffin said.
“We can prevent this vulnerability from occurring in the first place, which is a much more efficient use of resources. This partnership will provide mutual clients the guidance, resources, and support on an as needed basis to get things done right the first time, so they can focus on their business goals and objectives,” he added.