Malawer & Associates Consulting, LLC

Pharmaceutical, Chemical, & Dietary Supplement Value Creation
About us

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"At International Specialty Products, Dr. Malawer became expert in the chemistry, characterization, and analysis of specialty polymers, surfactants, and solvents. He has the demonstrated ability to analyze complex data sets in resolving critical problems. His written & oral communications are insightful. Dr. Malawer is a strong leader who shows commitment to do all things necessary to accomplish goals. I can recommend him without any hesitation ---"
Dr. Robert Ianniello
Director, Chemicals, Polymerization, & Refining Catalysts Research,
BASF Catalysts

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"I have known and worked with Dr. Malawer for many years. His skills as a scientist, educator, and research leader are very high. His many accomplishments in industry and within the field of Analytical Chemistry are abundant testimony to his intelligence, diligence, perseverance, and dedication to his work. I would strongly recommend Dr. Malawer as a potential consultant, expert witness, 3rd party auditor, or short course instructor without any reservations whatsoever."
Dr. Anthony J. Montana
VP of Scientific Operations
Garden State Nutritionals
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"Dr. Malawer's technical reports and oral communications are well done and are informative. Over the years, I observed him exhibit strong expertise in the fields of cGMP quality systems, process analytical technology, and laboratory design. He is an excellent scientist, manager, and strategic thinker with the demonstrated ability to solve problems. I can recommend him without hesitation ---"
H. Karl Krummel
former Asst. VP, Innovative Materials, R&D, L'Oreal
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. The firm additionally offers expert witness services in a variety of technical areas including intellectual property protection through analytical testing and product deformulation, pyrrolidone chemistry, process analyzers, cGMP of pharmaceutical excipients, and importation of chemicals. Malawer & Associates’ most recent business expansion this year has been in the areas of DMF creation and maintenance aimed primarily at Asian firms seeking to provide pharmaceutical ingredients for use in U.S. drug products.

Dr. Malawer has been retained as a lead auditor for the USP’s dietary supplement and pharmaceutical ingredients verification programs.
In addition, Dr. Malawer was named to serve on a newly-created USP steering committee on pharmaceutical education by Dr. Roger Williams, CEO of the USP. He has also served on the general chapter <1197> USP expert committee relating to excipient good distribution practices to which he contributed four sections.

In late 2009, Dr. Malawer was retained as an expert witness in an intellectual property dispute relating to pyrrolidone chemistry. The strong analytical testing program he designed for the client resulted in a favorable out-of-court settlement in the case in early 2010. He was also hired by a major food company to design an at-line analytical testing system to detect adulterants in received raw material food ingredients.
 

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 analytical methods while at ISP and established the process analytical function at that firm. He holds ten granted U.S. patents and has authored 35 peer-reviewed publications including several textbook chapters. Dr. Malawer's bibliography can be accessed (using Adobe Acrobat) by clicking here. 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.

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