Company History

Precision Scientific Consulting, Inc. was established in 2004 with the goal of providing exceptional validation services to clients in the Pharmaceutical and Biotechnology Industries. Since our inception we have expanded to provide a host of consulting services throughout all stages of the product and system life cycle.

 

Our Mission

Our mission is simple, we strive to provide exceptionally qualified FDA industry professionals with project specific skill sets to manage and complete projects efficiently, timely and with integrity.

“Precision Scientific Consulting has provided outstanding service in the execution of several complex regulatory compliance projects requiring independent management and attention to detail.”

What We've Achieved

Here is a sample of some of the projects we have successfully completed.

  • Qualification and startup of numerous multi-product biologic manufacturing facilities.

  • Qualification and startup of a chemical API manufacturing facility.

  • Facility design review for multiple GMP manufacturing facilities.

  • Development of training programs for the processes associated with the GMP manufacture of biologic products.

  • Support of several new product launches including process validation and assisting with CMC documentation.

  • Development aseptic process validation programs and validation of multiple aseptic processes.

  • Assessment and remediation of Data Integrity gaps for numerous complex computerized systems.

  • Quality Assurance support for new facility startup.