DYNALABS announces today that its consulting division has separated into the independent consulting group, AMICUS cGMP Consultants. New CEO & Principal Consultant, Kristopher Le, is based in Lexington, SC, and he assures everyone that AMICUS Consultants will continue to work with DYNALABS, LLC. AMICUS’ mission is to offer consulting services to pharmaceutical compounders and manufacturers, thus improving the overall safety and quality of their products. While AMICUS and DYNALABS will cooperate strategically, the separation into different business entities enables AMICUS to expand their service portfolio, and to provide services to a larger number of clients. This change does not impact DYNALABS’ ability to provide consulting to assist customers with matters related to product testing, such as stability study design, OOS investigations, and testing protocol development.
AMICUS cGMP Consulting will focus on more complex projects and clients while providing support to DYNALABS customers. “Over the past year, the demand for consulting to assist clients, particularly those required to follow cGMPs, has dramatically increased. In this rapidly changing regulatory environment, AMICUS is uniquely positioned to assist growing cGMP businesses become more compliant, efficient, and successful. We believe this is a positive strategic move because AMICUS can continue to work with DYNALABs clients, but now can also work also objectively with clients using competing contract laboratories,” say AMICUS CEO Kristopher Le.
AMICUS cGMP Consulting Group will continue to offer those services previously provided to clients. They will also offer more technical and regulatory services including: temperature mapping, autoclave and depyrogenation cycle validation, consent decree remediation, and 483 & warning remediation. By continuing to execute projects in a hands-on manner, and with a “going beyond reports” mentality, AMICUS separates itself from other consulting firms. The Team will continue to grow by adding consultants who have dealt with the same operational, regulatory, and business challenges faced by our clients.
For additional information about AMICUS please contact Kris Le
kle@amicusgmp.com
314.399.0213
