CERTIFICATION AND PERMITS

• Industrial manufacture and packaging of pharmaceuticals
  • EudraGMP certificate.
• Human investigational medicinal products
  • EudraGMP IMP certificate
• Medical Devices
  • ISO 13485 certificate
  • MDR compliance
  • MDD compliance
• Nutritional supplements
  • Our Oiva report can be found here.
  • Compliance with national food legislation
• Cosmetics
  • Compliance with national cosmetics regulation
• Animal feed mixes
  • Compliance with animal feed hygiene regulation
• Environmental management system
  • ISO 14001

QUALITY ASSURANCE 

Galena has an experienced quality assurance team that ensures compliance with all our processes and products. Our empoyees are committed to following GMP guidelines thus guaranteeing high-quality product manufacturing.

Our quality assurance operations include comprehensively:

• raw and packaging material sourcing and control
• manufacturing processes and manufacturing process control
• storage and transport
• quality control
• product batch certification and release
• risk assessment and management
• product development and process validations
• pharmacovigilance

For more information, contact our expert or fill out the contact form.