Savis Inc

Provides qualified leadership to assemble project personnel, establish schedules, and identify and resolve roadblocks to ensure project success.

• Turnkey Project Management

  Provides single-point accountability for turnkey projects, including the development of well-defined specifications and complete design packages.

Develops requirements and designs processes using modern technologies while meeting or exceeding industry regulations.

• Process & Equipment Engineering

  Designs processing lines and equipment systems tailored to meet stringent manufacturing standards.

• Facility & Structural Engineering

  Provides facility layout and structural design services for regulated production environments.

• System Integration

  Integrates sensors, processing lines, and packaging equipment into existing production systems.

Develops and executes commissioning, qualification, and validation plans efficiently to bring production online rapidly.

• Facility & Utility Validation

  Validates cleanrooms, HVAC systems, pure water, steam, and compressed air utilities.

• Process & Lab Equipment Validation

  Validates bioreactors, chromatography skids, autoclaves, and analytical laboratory instrumentation.

• Packaging Equipment Validation

  Validates vial washers, depyrogenation tunnels, aseptic fillers, lyophilizers, and cartoning lines.

• Computer Systems Validation

  Validates PLCs, HMIs, SCADAs, and GMP servers across major control system platforms.

Leverages deep knowledge of FDA, EMA, and MHRA regulations to support product commercialization and post-audit remediation.

• Audit Response & Remediation

  Assists client teams in preparing responses to and remediating audit findings and observations.

• Regulatory Filings & Submissions

  Supports the preparation of regulatory documentation and submissions to secure market compliance.

Modifies system hardware and software to enhance process control, display critical parameters, and increase reliability.

• Automation Software Implementation

  Implements and services control software from providers such as Rockwell, Siemens, Emerson, and Honeywell.

• Verification Systems

  Designs and installs automated systems for barcode, label, fill level, and lot code verification.

• Vision Systems Integration

  Integrates vision systems for character recognition, defect inspection, and packaging quality control.

Designs infrastructure and front-end systems using modern technologies while meeting regulatory compliance for electronic records.

• Infrastructure & Front-End Design

  Establishes secure, compliant IT networks, front-end systems, and database infrastructures.

• Data Integrity & Remediation

  Implements data integrity remediation solutions to secure and align electronic systems with regulatory expectations.