Alkemists Laboratories, a leader in natural products analysis and pioneer of cGMP botanical identity testing, announced it has expanded its service offerings to include a new R&D division focusing on finished product method development, verification and validation.
The new division is a strategic move to improve the service offerings of the company. After a recent expansion of the Alkemists Labs Herbarium (an onsite collection of over 10,000 specimens of ‘herbs of commerce’) in 2012, Alkemists increased its analytical lab space by 50 percent, which allowed an increased inventory of Waters™ HPLC/UPLCs by 20 percent and its analytical head count by 30 percent.
“An R&D division has always been in our strategic plan,” said Élan M Sudberg, CEO of Alkemists Labs. “It’s a joy to see our family business grow to a size that can now effectively execute high end analytical projects for companies making label claims on their finished products. It’s one thing to quantify the gingerols in a raw material of ginger; the moment that material is combined with another, that same gingerol value may no longer be scientifically valid by the same testing method. This is where our new R&D division steps in to assist our current client base as well as attract and service the quickly growing market of finished products with label claims.”
“In a 483 notice earlier this year, the FDA made clear they are not only hunting for cGMP violations but also companies who market finished products with label claims that have not been verified or validated,” said Sidney Sudberg, CSO of Alkemists Labs. “Between the array of Waters HPLC’s with various detectors we now have and the regulatory and multidisciplinary industry expertise of Kelly Reins, our executive director of lab operations and compliance, we are excited to offer pharmaceutical industry quality services to our current and future customers and continue our mission of providing peace of mind in the natural products industry.