Bioproduction

Supply chain

The production of both RUO and IVD kits relies on the supply of critical components. Firalis develops, validates and produces antibodies, standards and enzymes by biotechnological means, in high-quality grade, removing the discontinuation, customs, logistics, stock and scheduling risks of the supply chain.

Research products →Our new production facility →

1. Critical products
   • Antibodies
   • Proteins
   • Enzymes
2. Kit production
3. Sales

Kitting

Both RUO and IVD kits are produced at Firalis following ISO 9001, ISO 13485 and ISO 14001, guaranteeing traced and reproducible product performance from batch to batch.

ISO 13485:2016 certificate AFAQ 2014/58993.6Development and production, in HuningueQuality & certifications →

1. Critical products
2. Kit production
   • RUO
   • IVD
3. Sales

Regulatory affairs

Firalis offers regulatory affairs support, preparing and filing the dossier all along the development of your product, for both CE-⁠IVDR and FDA markets.

• Biomarker programme design
• Study planning
• Performance evaluation & clinical studies
• Standard operating procedures
• Regulatory dossiers
• Meetings with authorities

1. Biomarkers
2. Product validation
3. Regulatory technical file
   • CE-IVDR
   • FDA
4. IVD market

Distribution

Firalis supports kit storage, stock logistics, product transportation and sales. Stability studies can also be run at Firalis to determine optimum storage conditions and transportation costs.

Commercialisation Services →

1. Critical products
2. Kit production
3. Sales
   • RUO sales & distribution
   • IVD sales & distribution