Malawer & Associates Consulting, LLC was founded in August 2007 by Dr. Edward Malawer. Initially, the firm provided services in two distinct areas, process analytical chemistry (PAT) problem solving / project work as well as 3rd party, drug product CMO and ingredient supplier cGMP auditing. In late 2008, the company expanded its services in the area of technical education with a new 2-day short course for the American Chemical Society (ACS) entitled “Introduction to Process Analytical Chemistry”. Dr. Malawer subsequently created and presented a webinar on excipient quality and supply chain integrity for the United States Pharmacopeia. At present, the firm is primarily concentrating its efforts in the performance of cGMP audits in the dietary supplement, excipient, and pharmaceutical sectors (although we continue to support analytical method review and PAT initiatives).
Dr. Malawer has been retained since 2009 to the present as the principal lead auditor for the USP’s dietary supplement products, dietary supplement ingredients, and pharmaceutical excipient ingredients verification programs. He created the audit reporting protocol now used by all of the USP's Verification Department auditors.
Dr. Malawer received his B.S. degree in chemistry from the City College of the City University of New York. He also received M.S. and Ph.D. degrees in physical chemistry from New York University. Dr. Malawer spent the largest portion of his professional career (28 years) at GAF Chemicals, later called International Specialty Products (ISP), where he last served as Vice President responsible for corporate analytical R&D, product stewardship, quality assurance, and the technical library, leading an organization of 90 individuals. He supervised the creation and validation of circa 1500 new, validated analytical methods while at ISP and established the process analytical function at that firm. He holds ten granted U.S. patents and has authored more than 35 peer-reviewed publications including several textbook chapters. Dr. Malawer earned his Certified Quality Auditor (CQA) credential through the American Society for Quality (ASQ) in December 2007 and is a senior member of the ASQ. He has received additional, formal drug product cGMP training from ISPE / the GMP Institute.
Although Dr. Malawer is personally involved in every client project undertaken by the firm, larger projects are accommodated through the support of a number of Associates of the firm. These individuals are all highly seasoned consultants with specific expertise in key areas. (Click on the Associates link above to access their mini-bios.)