Malawer & Associates Consulting, LLC

Pharmaceutical, Chemical, & Dietary Supplement Value Creation

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Welcome to Malawer & Associates Consulting! We are an independent consulting firm dedicated to increasing value for our pharmaceutical, chemical and dietary supplement clients in all of the areas in which we provide support.

Our firm excels in the following disciplines:

Pharmaceutical & dietary supplement (cGMP) supplier auditing—Independent, 3rd party audits conducted on drug product ingredient suppliers and unit operation CMOs according to 21 CFR part 211 regulations. We also perform dietary (nutritional) supplement audits according to 21 CFR part 111 regulations.

Process analytical chemistry (PAC/PAT) - Assessment of opportunities for process improvement through on-line analysis and feedback control; coordination and/or management of projects through analyzer implementation stage; development of new, synergistic analyzer technologies.

Analytical method troubleshooting - Expert assessment of performance issues with existing analytical methods; optimization of method parameters to ensure high levels of accuracy and precision.

Expert Witness Services
—Intellectual property protection & challenge through analytical testing of product formulation; pyrrolidone chemistry; process analyzers; cGMP compliance of pharmaceutical excipients, drug products and nutritional supplements; importation of chemicals -- proof of substantial transformation. 

Education—Creation of and teaching technical short courses in process analytical technology/chemistry and pharmaceutical excipient quality; authoring of reference texts; technical writing.

Drug Master File (DMF) Services— Creation and annual maintenance of pharmaceutical active (API) and inactive (excipient) ingredient drug master files in the Common Technical Document (CTD) format required by the Food & Drug Administration.

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Malawer & Associates Consulting, LLC

24 Terrace Road
Wayne, NJ 07470-3032, USA
(973)896-1118
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