NIR-INDUSTRY: ProcessControlExpert
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Contact
2 place de Touraine
78000 Versailles
France
Gérant
About us
Since 2019, ProcessControlExpert has positioned itself as the first Center of Expertise dedicated to operational excellence in R&D, industrialization and production in the (bio)-pharmaceutical and chemical sectors. Combining the strengths of Inhalexpert, Nir-Industry and Galenisys Pharmaceutical Consultants, we offer unparalleled expertise in QbD development, PAT technologies and analytical method validation.
Commitment: Our mission is to optimize the quality, efficiency and compliance of our customers' processes, in R&D and in production, through an integrated approach and advanced technological solutions.
Your Trusted Partner: With ProcessControlExpert, benefit from expert support to transform your analytical challenges into opportunities for operational excellence.
Business offer
Our Key Services:
QbD & PAT expertise: Complete support from Quality by Design (QbD) to process monitoring through the implementation of advanced PAT systems (NIR, RAMAN, ECT & ERT Tomography, Imaging).
Regulatory Compliance: Rigorous support for the validation and adjustment of analytical methods, ensuring compliance with FDA and EMA standards.
Advanced Technologies: Sale, installation and training on cutting-edge PAT equipment in NIR, RAMAN, ECT & ERT Tomography and Imaging, suitable for all environments (field, laboratory, process).
Technical Support and Training: More than 20 years of experience in spectroscopy and associated technologies, guaranteeing complete support from consultation to maintenance, including installation and training on chemometrics software (Vektor Direktor, Unscrambler).
Activities
- Service
- Technology Supplier
- Other
- Bioproduction
- Batches production type
- Mammalian
- Insect
- Yeast
- Bacterial
- GLP compliance
- GMP compliance
- Pilot Batches
- Tests
- Optimization
- Scale-Up process
- Process optimization & validation
- Volume
- Preclinical / Tox
- Low volume (< 200 L)
- High volume (200 – 2000 L)
- Very high volume (> 2000 L)
- Commercial
- USP (Scale-Up)
- Cell expansion
- Inoculation
- Low volume containers to Bioreactors
- DSP (Recovery)
- Harvest
- Filtration
- Purification
- Fill & Finish
- Aseptic filling
- Lyophilization
- 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
- Contaminants detection
- Biosafety & Bioanalysis
- Toxicology
- 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
- CMC/analytical quality assessment, quality control
- Cleaning
- Cross contamination
- Contaminants detection
- Bioproduction engineering
- Purification/Extraction
- Chromatography
- Bioproduction modeling
- Control / command
- Global optimization
- Artificial Intelligence tools
- Quality control & analytical process monitoring
- Stability Assessment
- Biosafety & Bioanalysis
- Toxicology
- Bioproduction analytical monitoring
- Key and critical process parameters (KCP, CPP)
- Identification
- Monitoring
- Batch release test
- Chemical, physical, biological testing
- Impurities detection
- Quality control test support
