Regulation in the Pharmaceutical Industry is increasingly important.
Ellion's consultants assist you to reach GXP standards compliance which is essential to ensure that products are manufactured with a safe and consistent process.
- QA operations
- QA system
- QA validation
- GXP compliance
- Sterility assurance
Qualification & Validation
Commissioning, qualification and validation are extremely critical in pharmaceutical processes to meet GXP guidelines.
Let our consultants bring you the necessary expertise to manage your production equipments' life cycle.
- Equipment validation
- Process validation
- Cleaning validation
Manufacturing in the Life Sciences industry has changed drastically over the past few years, and bigger evolutions are yet to come.
Improving productivity by integrating new technologies is the new challenge, and Ellion's team is your preferred partner in this ever changing industrial context.
- Industry 4.0
- Process automation
- Production supervision
- Deviation and CAPA
From the exploratory phase to the final commissioning, our consultants have the right mindset and expertise to support all your engineering projects.
- Conceptual, basic, detailed design
- Maintenance & releability
- Process engineering
- Technical environments:
HVAC, utilities, electricity,
The industry is facing an increase in quality control strictness. Data integrity, computerized system and digitalization are becoming a must to implement.
Our team support you in facing those new challenges from analytical methods development to samples analysis processes,
- Analytical development
- Validation of methods analytics
- Analytical transfer
- QC activities
GXP compliance is required by OECD countries and United States FDA to ensure that proper guidelines are followed in the manufacturing of APIs, excipients and finished drug formulations
Our qualified experts manage and supoprt you in all the phases of a succefull audit.
- GMP Audit
- Quality Audit
- Supplier Audit
- Pre/post inspection Audit