EYLIO SAS
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Contact
500 boulevard sebastien brant
67400 Illkirch-Graffenstaden
France
Business Developper
About us
Eylio is a pharmaceutical company specialized in GMP and GDP regulated activities. It provides high value-added services including importation, storage, Qualified Person (QP) release, secondary packaging, and logistics management for both investigational and commercial medicinal products.
Eylio also ensures regulatory compliance across the entire manufacturing supply chain, from the active pharmaceutical ingredient (API) to the finished product, including at an international level. The company supports its partners with site qualification, operational oversight, quality review, and inspection readiness for Health Authorities (ANSM, EMA, FDA).
Positioned as a strategic partner for biotech companies and pharmaceutical laboratories, Eylio combines regulatory expertise, quality rigor, and operational flexibility to secure market access and international development of healthcare products.
Business offer
Eylio SAS provides an integrated range of pharmaceutical services under GMP and GDP environments, supporting biotech companies, pharmaceutical laboratories, and healthcare organizations in both clinical and commercial phases.
1. Regulated Activities (GMP / GDP)
- Importation of medicinal products and active pharmaceutical ingredients (APIs)
- Storage (ambient, refrigerated, and specific controlled conditions)
- Qualified Person (QP) batch certification and release
- Secondary packaging and related operations
- Logistics management and distribution, including clinical supply
2. International Compliance & Oversight
- Regulatory compliance across the entire manufacturing supply chain, from API to finished product
- Qualification and audit of subcontractors (CMOs, CDMOs, laboratories)
- Gap analysis and inspection readiness (ANSM, EMA, FDA)
- Quality system structuring and pharmaceutical oversight
3. Strategic Support
- Support for European market access
- Outsourced pharmaceutical organization (Responsible Pharmacist / QP services)
- Management of complaints, recalls, and deviations
- Regulatory and supply chain strategic consulting
Positioning: An agile and expert partner dedicated to securing regulatory compliance and optimizing pharmaceutical operations in demanding international environments.
Activities
- Service
- Pre-industrial demonstrator
- Consulting
- Genetic Diseases
- Oncology
- Nervous Central System
- Hematology
- Infectiology
- Immunology
- Ophthalmology
- Inflammation
- CMC
- GLP compliance
- Master Cell Bank
- Production
- Cell Line development
- Clone selection
- Characterization
- Storage
- Analytical development
- Cell Culture
- Media composition
- Bioreactor conditions
- Gene modification / Transduction
- Retroviral & lentiviral vectors
- Cell expansion
- Wave-mixed bioreactors
- Stirred tank reactors
- Bioproduction
- Batches production type
- Mammalian
- GMP compliance
- Pilot Batches
- Tests
- Optimization
- Scale-Up process
- Process optimization & validation
- Batch release
- Storage matter
- Instruction
- Logistic
- Cell cryopreservation
- Controlled-rated freezer
- thaw
- Quality assurance, quality control & analytical process
- Stability Assessment
- Physical & chemical profile
- Shear/shaking
- Viscosity
- Photostability
- pH
- Freeze/thaw
- Heat/degradation
- Aggregation
- Cell line analytical development
- Host cell proteins
- Viral clearance
- Contaminants detection
- Biosafety & Bioanalysis
- Toxicology
- Non-clinical safety and toxicology studies
- PK/PD features
- Impurities detection
- Bioproduction analytical test
- Monitoring
- Characterization
- Batch consistency
- Batch release test
- Chemical, physical, biological test
- Quality control test support
- Post-production test
- Real-time stability test
- Clinical trials
- Phase I
- Phase II
- Phase III
- Phase IV
- Regulatory filing
- Regulatory Filing
- Cell origin
- Cell Banking
- IPs
- MSC
- CD34 + HSC cells
- Tissue acquisition
- CMC/analytical quality assessment, quality control
- Cleaning
- Cross contamination
- Sterility
- Contaminants detection
- Safety for gene-edited cells
- translocation
- anti-nuclease response
- cytokine-independent growth
- Non-clinical safety and toxicology studies
- Bioproduction engineering
- Cell Expansion
- Stirred tank Bioreactor
- Wave bioreactor
- Cell factory
- Microcarrier-based culture
- Organoids culture
- Capsules culture
- Scale-Up
- Process optimization
- Automated manufacturing
- On-line monitoring
- Automated high throughput microbioreactor system
- Non-GMP expansion
- GMP expansion
- Other
- Purification/Extraction
- Filtration / microfiltration / ultrafiltration
- Centrifugation
- Chromatography
- CGMP
- Bioproduction modeling
- Metabolic / Kinetic modeling
- Control / command
- Global optimization
- Economic analyses
- Artificial Intelligence tools
- Formulation
- Conditioning
- Storage
- Delivery
- Transport
- Supply chain logistics
- Tracking process
- Monitoring logistics
- Cell procurement
- Autologous
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Bioproduction
- Scale-Up
- Automated manufacturing
- Automated high throughput microbioreactor system
- Supply chain logistics
- Tracking process
- Monitoring logistics
- Non-GMP pilot batch
- GMP batch
- Cleaning
- CGMP
- Sterility
- Deviations
- Quality control
- Contaminants detection
- Safety for gene-edited cells
- Translocation
- anti-nuclease response
- cytokine-independent growth
- Non-clinical safety and toxicology studies
- Vaccine: antigen format platforms
- Recombinant protein expression
- Bacterial
- Cell
- Fungi
- Synthetic Peptides or oligomers
- Virus-like particles (VLP) and nanoparticle-based carriers
- CMC
- GMP compliance
- Master Banks (cell and viral as needed)
- manufacturing
- Characterization and testing
- storage
- shipment
- Cell Culture / Fermentation
- media formulation and supply
- Bioreactor conditions (cell in suspension, adherent cell player)
- Ability to work in BSL2 conditions
- Cell expansion
- Single use technology (SUS)
- Wave-mixed bioreactors
- Stirred tank reactors
- Gene modification / Transduction
- Molecular biology
- Expression systems
- Vaccine delivery/Administration routes
- Route of Administration
- Intramuscular route
- intradermal route
- Nasal route
- Mucosal routes
- Other devices: specify
- Delivery/ Encapsulation
- Polymeric Nanoparticles
- Lipid Nanoparticles
- Nano emulsions
- Adjuvanted delivery systems
- Regulatory safety
- Specificity
- Human sequence homologies
- Regulatory safety tests
- Viral safety
- Immunotoxicology
- Non-clinical safety and toxicology studies
- Clinical trials
- Phase I
- Phase II (human challenge trials)
- Phase III (large population pending pathogen prevalence)
- Immune monitoring
- Data management
- Bioproduction GMP
- Vaccine platform type
- Recombinant protein expression
- Synthetic Peptides or oligomers
- Virus-like particles (VLP) and nanoparticle-based carriers
- killed/inactivated virus
- Live attenuated virus
- Viral vector encoding target antigen
- DNA plasmid vaccine
- mRNA vaccine
- Lipid delivery vehicle
- Outer-membrane vesicles (OMV)
- Polysaccharides/ conjugated vaccines
- Other
- Pilot Batches scale
- Process development & optimization
- Scale-Up & Validation
- Comparability characterization protocol
- Manufacturing Volume
- Small volume (< 100 L) adjusted to phase I/II needs: specify volume
- Large volume (100 – 1000 L) adapted for phase III needs
- Final scale up volume (> 1000 L) and validation for manufacturing
- Commercial supply during life cycle management
- USP (Scale-Up)
- Fill & finish
- Lyophilization
- Prefilled syringe
- Vaccine shipment and distribution
- Storage matter
- Labelling
- Packaging for shipping
- Instruction Label
- Digitalization of bar code
- Cold chain logistics
- Quality control & analytical process monitoring
- Stability Assessment
- Biosafety & Bioanalysis
- Toxicology
- Immune response characterization
- Viral safety
- Bioproduction analytical monitoring
- Key and critical process parameters (KCP, CPP)
- Identification
- Monitoring
- Batch release test
- Chemical, physical, biological testing
- Potency assay
- Challenge animal models
- Impurities detection
- Quality control test support
- Regulatory Filing
- Regulatory Filing
- New Drug Application (IND)
- Investigational Medicinal Product (IMPT) for clinical investigations (EMA)
- Common Technical document (CTD) section 3 (CMC) 4 (NCS) and 5 (Clinics) for submission

