ISO-61143 – Injectable Biotech Standards

Certification Overview

The ISO-61143 certification applies to companies producing injectable biotech formulations, ensuring sterility, purity, and compliance with global biotech regulations.

Who Can Apply?

• Pharmaceutical injectable manufacturers

• Peptide & biologic drug developers

• Hyaluronic acid injectable brands

• Clinical research organizations

Compliance Criteria

• Compliance with injectable sterility requirements

• Particle contamination & endotoxin testing

• Validation of injection delivery systems

• Documentation proving formulation stability

Benefits of Certification

• Facilitates regulatory approval in major markets

• Increases physician & patient trust in injectables

• Ensures compliance with pharmaceutical safety guidelines

• Enables premium pricing for certified products

Fees & Processing Time

• Application Fee: £100 (Non-refundable)

• Audit & Assessment Fee: £1000 (Full review & compliance check)

• Annual Surveillance Fee: £150 (Yearly compliance review)

• Processing Time: 6-12 weeks

How to Apply

To apply for this certification, visit the Apply for Certification page and complete the application form.