Excellence is Not
an Accident.
Every product leaving our facility has passed rigorous testing and validation. Quality is embedded in every process, every decision, and every product we deliver.
Quality at Every Stage
We are committed to customer satisfaction, continuous improvement, and adherence to the highest standards of quality and regulatory compliance. Our comprehensive quality management system ensures consistent, reliable products across every production run.
Quality Commitment in every batch
Controlled cleanroom manufacturing
Every batch rigorously inspected
Certified by accredited registrar bodies
Official Certifications & Accreditations
Explore and download our official audit certificates, confirming adherence to global medical device and primary pharmaceutical packaging directives.
ISO 13485:2016
Medical Devices Quality Management System
Certified by BSI for the design and manufacture of medical device components and primary pharmaceutical packaging.
ISO 9001:2015
Quality Management System
Demonstrates consistent quality compliance, manufacturing process precision, and customer satisfaction assurance.
ISO 15378:2017
Primary Packaging Materials for Medicinal Products
Specifies GMP requirements and quality management for primary packaging materials utilized in medicinal products.
EU MDR 2017/745
Medical Device Regulation Conformity
Conformity assessment certificate under European Medical Device Regulation standards for pharmaceutical dosing devices.
UKCA Conformity
UK Conformity Assessed
Conformity certification for medical packaging and dosing devices for distribution throughout the United Kingdom.
US FDA DMF — Type III
Drug Master File No. 033932
Assigned US FDA Drug Master File (DMF) Number 033932 for Type III Packaging Materials covering pharmaceutical packaging and dosing devices.
Health Canada
Master File MF 2026-104
Health Canada Master File MF 2026-104 covering plastic bottles, caps, dropper assemblies, measuring caps, oral syringes, and adapters for pharmaceutical packaging.
Standards & Testing Protocol
Incoming Material Inspection
Certificate of Analysis verification, moisture analysis, melt flow index testing, and polymer batch traceability.
In-Process Quality Control (IPQC)
Dimensional verification, wall thickness measurement, weight consistency checks, and visual defect monitoring at defined intervals.
Finished Product Testing
Leak testing, torque testing, drop testing, sterility assurance validation, and graduation accuracy verification for dosing products.
Regulatory Support & Compliance
Certificates of Analysis (CoA)
Provided with every shipment detailing batch-specific testing results, raw material lot numbers, and specification compliance.
Material Safety & Compliance Data
USP Class VI certificates, FDA 21 CFR compliance declarations, BSE/TSE statements, and extractables & leachables profiles available on request.
Change Control Management
Formal change control procedure with advance customer notification for any raw material, tooling, or process modifications.
Need Quality Documentation?
Request Certificates of Analysis, technical data sheets, regulatory compliance packages, or schedule a facility audit with our quality assurance team.
Contact Quality Team →