Steyer Consulting Engineering Resources Llc

Steyer Consulting Engineering Resources provides a broad range of Engineering Services from: Aseptic Process Development, Aseptic Process Optimization, Small Molecule & Biologics Process Development both Up-Stream & Down-Stream, Small Molecule & Biologics Process Optimization, and Validation Engineering on: Large Capital Projects, both Green Field & Brown Field Builds, Remediation Projects, Clinical Trial Process Development, and Equipment Design: both Conventional and Single-use-Systems. Steyer Consulting Engineering Resources provides services for: Scale-up, Technology Transfer, Validation, gamma, e-Beam, VHP, & Steam Sterilization development, Pre-Approval Inspection Readiness, Extractables & Leachables Protocols and Risk Assessments, and Training for the pharmaceutical and medical device industries. Steyer Consulting Engineering Resources previous projects involved: Designing new novel aseptic single-use systems, aseptic facilities, and aseptic equipment to writing and executing all types of engineering documents BOD, EPP, URS, FAT, SAT, IOPQs, PPQs, Contamination Control Strategies, and protocols to data-based risk assessments, pFMEA, sFMEA, HACCP, to Capital Appropriation Requests and Engineering Change Orders. Steyer Consulting also specializes in: statistical quality control analysis, measurement system analysis (Gauge R&R), analytical analysis, design of experiments: Resolution Fractional Factorial Designed Screening Experiments and Design of Experiments, Computer modeling, Monte Carlo Simulations, and Computer Aided Design (CAD) with: R Statistical Language, SupperPro Designer, Simsci’s ProII, AFT Fathom, JMP Pro, & AutoCAD. Steyer Consulting Engineering Resources is Experienced and intimately familiar with all aspects of regulation involving: FDA, EMA, HMRA, Heath Canada, TGA (Australia), COFEPRIS (Mexico), AIFA (Italian), HPRA (Irish), CFDA (China), and PMDA (Japan), ISO, ICH, PDA, ANSI, AAMI, USP, Regulatory Standards.