Our Process

Serving You With a Well-Defined & Certified Production Process

When you’re looking for a packaging and labeling partner, you’re searching for a company that has a well-defined process! Our seven-step process provides the confidence and transparency you need to bring your project to life.

Needs analysis

We begin by identifying the optimal drug packaging based on the unique demands of the product, branding and applicable regulations

Concept evaluation

Once we’ve determined the best solution, we prove it by conducting a feasibility study, initial testing and material review in compliance with ISO, FDA, REACH and other regulations.

We also consider your security, product performance and innovative applications improvements.

Pre-production planning

Next, we work with you to establish timelines to ensure we meet every milestone. This planning includes:

Reviewing samples and prototypes
Establishing initial production methodology
Performing quality-control testing
Linking critical requirements within the ERP system

Proofing

The quality of your products is our greatest concern. We assure this by creating proofs of your label and packaging to check accuracy. This process could include ink drawdowns, 3D modeling and/or production press proofing.

Pre-production approval

We validate the product and application before the rollout. If you want samples, we can do that!

Customized production

Products are then manufactured in accordance with ISO 13485 standards, including:

Regulatory compliance assistance and component verification testing (e.g., trace element analysis, performance and composition certification, etc.)
Security controls best suited for your needs
Line clearances, area segregation and individual product cages throughout the converting process
Complete inline text verification
Backside consecutive numbering for label count reconciliation
Finish rolls with leaders and trailers as required, and perfect roll tension to ensure smooth operation on application equipment
Sealed and securely wrapped pallets of finished goods to support FDA/GS1 initiatives

Complete chain of custody within a secure production facility

Documentation

Document controls offer you complete product traceability in line with current good manufacturing practices (cGMPs). This process includes:

Full raw material and shipment chain of custody
First piece validation by internal PCM
Certificate of compliance supplied with each shipment
Final QC inspection and approval
Product record finalized with the ERP system

We Know Packaging and Labeling

Every detail of RLG Healthcare’s process is designed to deliver the components essential to your operations and remove stress from DSCSA compliance and other regulatory requirements.

Contact us to find out more about our best-in-class solutions for print and packaging that make your job easier and exceed expectations.

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Our Certified Facilities Keep You Compliant

Never second-guess whether your industry requirements are being met. Our facilities have many quality certifications, including facilities that have achieved multiple ISO standards — ISO 9001:2015, ISO 15378:2017, ISO 13485, ISO 9008:2015.

Introducing RLG Healthcare – Compliant. Responsive. Full Service.

Our Process

Serving You With a Well-Defined & Certified Production Process

Needs analysis

Concept evaluation

Pre-production planning

Proofing

Pre-production approval

Customized production

Documentation

We Know Packaging and Labeling

Our Certified Facilities Keep You Compliant

Contact Info