VALIDAPRO EUROPE
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Contact
18 rue Jean Perrin ZI Actisud le Chapitre
31100 TOULOUSE
France
Chargée de Développement Commercial
About us
VALIDAPRO is a service provider for the pharmaceutical, biotechnology and medical device industries.
VALIDAPRO is also: two multidisciplinary teams, present on two continents and made up of experts who come together for a mission and a main objective:
Provide a wide range of specialized services covering all regulatory needs from discovery to commercialization of a drug or medical device.
Business offer
VALIDAPRO offer its expertise in the following areas :
* Compliance : Audits, advisory support, regulatory files, training,
* Qualification-Validation : PDV, risk analyses, QC QI QO QP on equipment and utilities, Process validation.
- * Continuous Improvement : VSM, Kaizen projects, Lean project management.
VALIDAPRO has an international expertise in compliance, notably from the FDA, EMA, ANSM, ANVISA, Japan and Health Canada, which closely combines Quality and the industrial approach.
The approach developed for each project is focused on compliance with regulatory expectations and the effectiveness of the solutions proposed and developed with respect and transparency in partnership with our clients.
Activities
- Service
- Immunotherapy lead generation
- Manufacturability
- Production quality
- CMC feasibility
- CMC
- GLP compliance
- 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
- 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
- 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
- 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
- Formulation
- Formulation
- Dose
- Stability
- Excipients
- Adjuvants
- Sterilization
- Lyophilization
- Storage stability
