Helping you succeed!
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 and ingredient 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.