Donald Klein, PhD DLK Consulting Services

Donald N. Klein, Ph.D., is a CMC Consultant with DLK Consulting Services, Inc., a small business incorporated in July, 2019.  Don provides CMC consulting and advisory services for pre-IND, IND, NDA, ANDA, BLA, PMA, and/or DMF (Type II, III, IV, and V).  He retired from the FDA in September, 2017 after a total of 23 years as a Senior Review Chemist (new drugs) and 5 years as post-marketing CMC Lead (2013 – 2017).  Starting in 1997 Don contributed to the following CDER packaging projects:  Committee Chair (2000 – 2003);  3 Guidances (1997 – 2003); comparability protocols (1999 – 2017); DMF Strike Force (2000 – 2004);  FDA Liaison to the USP for <659>; <660>; <671>; and <1660>; USP PDEC Member (2015 – 2017); and internal FDA training seminars (2000 – 2017). Don’s public service accomplishments were recognized by the FDA Commissioner (Dr. Gottlieb) via the FDA Distinguished Career Award (2017).  Don brings CMC consulting experience through his work with a large CRO organization from 2017 – 2019  where his work  resulted in an approved NME NDA, an NDA under review, a PAS approval (NME NDA) to support a multimillion dollar investment, and 2 NME, pre-IND – IND submissions permitted to initiate clinical studies.