Services Included

Depending on your subscription level, we provide all the Cleanroom, Facility, HVAC, Utility, Calibration, Maintenance, Validation, Supply Chain, Cleaning, Environmental Monitoring, and Quality System services so that you can focus on what you do best, develop life-saving medicines and protect patients.

We operate a centralized management and a decentralized operations model to ensure cost efficiency and regulatory compliance. We partner with qualified vendors for any support activities not performed in-house.

ISO Certified Cleanrooms

Modular Design

Our Cleanrooms are designed and built using the latest technology and standards. Our modular approach allows us to quickly expand manufacturing as required. All cleanrooms are qualified to ISO-14644 standards.

Qualified HVAC and Critical Utilities

Validated

We risk assess each system to determine the appropriate level of qualification. We commission and qualify following FDA, EU, PIC/S requirements using industry best practices from ISPE, ASME, and the PDA.

Compliant Electronic Systems

Data Integrity

Reliable data is critical in GMP manufacturing. We use enterprise-grade cloud-based IT systems for Quality Management, Documentation, Training, Supply Chain, Calibration, Maintenance, and Validation operations.

Supply Chain Management

ERP System

We take care of all Supply Chain and Warehousing operations on our enterprise-grade ERP system. We perform vendor qualification and management and store all your temperature sensitivetemperature-sensitive materials in qualified Fridges, Freezers, or Liquid Nitrogen.

Cleaning and Environmental Monitoring

Validated Cleaning

We perform continuous Cleaning and Environmental Monitoring of the cleanrooms. We use validated detergents, biocides, and sporicides to ensure cleanliness. We ensure that all cleanrooms are maintained within viable and non-viable particle limits as defined in ISO 14644.

Basic Quality Control Testing

QC Testing

We perform all Environmental and Critical Utility Monitoring in-house to ensure compliance with regulated standards. We can perform additional basic QC testing to support your operation. Please discuss your QC testing requirements with us.

Calibration and Maintenance

CMMS System

We manage and perform all Calibration and Maintenance activities to ensure ongoing compliance and reliability. All executed data is stored in our GxP compliant Calibration Maintenance Management System (CMMS). We can manage the calibration and maintenance of your process equipment also.

Ongoing Facility Validation

Validation

We ensure ongoing compliance to regulatory standards by performing Periodic Reviews and Periodic Revalidation on all systems, including requalification of the Cleanrooms, Bio Safety Cabinets (BSCs) Incubators, Fridges, Freezers, and Liquid Nitrogen freezers. We can support youyour validation efforts also.