About
The Malash Group builds confidence.
A practice built on technical judgment: executive-level direction paired with the willingness to do the work on the floor, in the laboratory, and in front of the regulator.
Experience Behind the Practice
The Malash Group™ is led by a microbiology professional with more than twenty years of experience in pharmaceutical quality, environmental monitoring, contamination control, and laboratory operations. That experience spans biologics, vaccine manufacturing, medical devices, and pharmaceutical compounding, combining technical leadership with direct work in laboratories and manufacturing facilities.
The practice’s principal has established microbiology and environmental monitoring groups from the ground up, expanded an additional monitoring group to support 503B compliance, and led teams supporting the transition of three facilities into production. Responsibilities have included program design, facility qualification, laboratory development, personnel training, and implementation of sustainable quality systems.
Experience includes representing microbiology and environmental monitoring functions during FDA and EMA inspections, as well as client and internal audits, along with direct leadership in the remediation of FDA Form 483 observations. This includes leading three remediation efforts addressing 483 observations, with no subsequent warning letters issued. Technical work encompasses microbial risk assessments, environmental monitoring performance qualification, contamination investigations, sterility, bioburden and endotoxin testing, and the development of procedures, qualification studies, and trending programs.
A background in biology, complemented by an MBA in Finance, brings an understanding of both scientific requirements and the operational decisions facing pharmaceutical organizations. Through The RIBS Method™ (Recover, Improve, Build, Scale), the practice helps clients resolve immediate challenges and develop the people, programs, and systems needed for continued operation and growth.
Executive level
Strategy, regulatory position, and organizational decisions.
Inside the operation
Investigation, method, monitoring, training, and qualification.
How engagements run
Engagements may be on-site or remote, and commonly run over an extended implementation period rather than a short review. Work is handled with discretion; most of it sits under non-disclosure agreements, which is why the engagement records on this site are anonymized.
