To help eliminate gaps where many companies are failing GMP audits, New Dietary Ingredient (NDI) applications, and other regulatory-related responsibilities, Alkemist Labs, a contract testing lab specializing in botanical identity and potency testing, is collaborating with REJIMUS, a regulatory management solutions provider, to offer clients comprehensive GMP compliance solutions.
 
“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,” said Alkemist Labs CEO Elan Sudberg. “And many GRAS (Generally Recognized as Safe) 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 providing many of the required components can help improve that record.”
 
Alkemist and REJIMUS offer clients 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. Alkemist and REJIMUS will have key personnel and resources dedicated to helping fast-track the development and submission of more first-time successful GRAS and New NDI Notifications, compared to industry averages.
 
“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,” said Brandon Griffin, CEO of REJIMUS. “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.”
 
This new partnership will empower a wide range of businesses to become fully compliant with regulatory requirements, and maintain their compliance, for example:
 

• For novel ingredient development companies: complete and compliant methodologies and data sets to first-time successful ingredient filings, specification creation and optimization, clinical studies and label claims development.
• For own-label marketers and distributors: verification that their manufacturers and suppliers are making products to specifications and the products will meet label claims and other requirements, including the shelf-life.
• For contract manufacturers: routine testing support, strategic planning and production optimization, troubleshooting non-compliance matters quickly, and having pre-qualified lab resources in place to support any seasonality, ingredient and formulation transitions, or ad-hoc development requirements.
• For major retailers, high throughput label reviews and rapid testing to verify label information, and other support for other documentation needs (e.g., SDS, FDA Facility Registration, Food Safety Plans).