For more than twenty years, we have helped our pharmaceutical clients, successfully plan, implement, and commission facilities and processes for new products. Our licensed engineers have worked in concert with the client professionals to ensure that the facilities and processes meet FDA requirements and all pertinent local, state and federal codes.
Our services have included project management, site & space planning, budgeting, equipment layout, engineering & design, fieldwork, code searches, state permitting assistance, bid document preparation, bid assistance, client advocacy with contractors in the field, commissioning, validation, IQ/OQ, SOP development, FDA audit assistance and industrial IT.
Our successful design projects have included raw materials handling, liquid processing, wet cell processing, dry blending cell processing, tablet/encapsulation cells, tablet coating cells, packaging line installations and many associated process and utilities installations.
Areas of Expertise:
- Process Installation Design
- Computer Validation
- Installation Qualification/Operational Qualification (IQ/OQ)