Malawer & Associates Consulting, LLC
Pharmaceutical, Chemical, & Cleantech Value Creation
Services
Malawer & Associates Consulting, LLC is pleased to offer consulting services for the pharmaceutical, chemical, and cleantech industries in four discrete disciplines of core competency. Our firm also offers expert witness services in the areas of analytical testing of product formulation; pyrrolidone chemistry; process analyzers; and cGMP compliance of pharmaceutical excipients, drug products and nutritional supplements. Please proceed to the dedicated web page for each for more detailed information by clicking on the title of interest.
Process Analytical Chemistry (PAC / PAT)
On-line analysis performed directly upon a pharmaceutical or chemical process can be used to control the process via feedback through an existing DCS or PLC system. This results in increased quality, reduced raw material usage and waste generation, increased yield, lower operational cost.
We provide chemical and pharmaceutical process assessment, guidance on optimum analyzer selection, and analyzer project management through the implementation phase, as needed. We can also provide on-site (short course) training on process analytical chemistry (PAC/PAT).
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Educational Materials Development
The continuing education of employees is critical to their success in producing high quality products to ensure the ongoing profitability of their companies. This is best addressed through the use of on-site short courses enabling employees to be trained economically with minimal time away from the job.
We can deliver the PAC short course originally developed for the American Chemical Society on-site at low cost to any size group of employees. We are currently producing another short course for the USP on excipient quality and supply chain integrity.
Pharmaceutical cGMP Supplier Auditing
We perform 1-3 day on-site drug product audits of the key operations and documentation of clients’ suppliers according to the 21 CFR part 211 regulations. We employ a very comprehensive questionnaire and produce a highly detailed audit reports with completed corrective action request forms as needed.
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The high cost of foreign petroleum as well as mounting environmental issues relating to the burning of fossil fuels and waste management in general has accelerated the development of clean technologies (‘cleantech”). The associated green and sustainable innovations are mostly due to small, start-up firms.
In partnership with O Vicus Professional Services, we support the development of such firms through assessment of their technologies and IP, assistance in gaining investor funding, and market development in North America.
