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We help our clients to validate the designs and operations as per international regulatory norms and standards.

We believe that our products are useful to our customers only if they can be qualified backed with good documentation. We have a FAT centre dedicated to qualifying our equipment prior to leaving the factory.

The equipment qualification approach is in alignment with GAMP, ISPE, and ASTM E2500 where by validation support activities and documentation focus on what is critical for end- product quality and are scaled according to customer requirements based on risk and complexity.

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Our Validation Services

• Validation Master Plan
Our Validation Master Plan, outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility.
• IQ support
Our IQ service verifies that the equipment, and its ancillary systems or sub-systems have been installed in accordance with installation drawings and or specifications. We also provide complete support for installation of systems
• OQ Support
Our Operational Qualification service includes a review of the Standard Operating Procedure (SOP's) for start-up, operation, maintenance, safety, and cleaning / sanitization as applicable, all in a fully approved format.
• Documentation
Our service includes verification of a given equipment and checks consistently if it produces the product (or product part) within defined specifications.
• Process Validation
Our Process Validation service includes analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products as per given regulations.
• Cleaning Validation
Our Cleaning Validation service assures that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.
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