Julie Canovas, Freelance Consultant
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Contact
17 Rue du mesnil
44230 St Sebastien sur Loire
France
Freelance Consultant
About us
After 15 years in the biotech and pharma industries, I decided to create my own freelance organization in May 2023 in order to collaborate with my partners in this specific field anywhere in France.
Being fully dedicated in solving your challenges, we will build together tailored solutions, according to your needs, with a pragmatic and holistic reflexion. My 360° approach includes overview of processes, teams as well as global context of your company and its environment and history.
Business offer
I am guiding you in building your impacting and structuring projects, with both objectives of quality and efficiency.
My services are particularly adapted to young start-up looking support for quality system implementation, tech transfer lead, complex projects piloting, as well as coaching to manage organizational changes in a fast-growing environment.
I'm giving advices combining strategic assets, facilitation of workshops, coordination of teams, building tailored trainings, creation and deployment of tools, operational coordination and involvement in recruitment as required.
Activities
- Service
- CMC
- GLP compliance
- GLP compliance
- Master Cell Bank
- Production
- Cell Line development
- Clone selection
- Characterization
- Storage
- Analytical development
- Cell Culture
- Media composition
- Bioreactor conditions
- Cell expansion
- Wave-mixed bioreactors
- Stirred tank reactors
- Bioproduction
- GLP compliance
- GMP compliance
- Pilot Batches
- Tests
- Optimization
- Scale-Up process
- Process optimization & validation
- Fill & Finish
- Aseptic filling
- Batch release
- Storage matter
- Instruction
- Logistic
- Cell cryopreservation
- Controlled-rated freezer
- thaw
- Quality assurance, quality control & analytical process
- 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
- Regulatory filing
- Regulatory Filing
- Cell origin
- Cell Banking
- IPs
- MSC
- Target cell isolation
- iPS reprogramming
- Differentiated Cell
- Production Cell
- Cell modification
- Cell Activation
- Bioproduction engineering
- CGMP
- Formulation
- Conditioning
- Storage
- Delivery
- Transport
- Supply chain logistics
- Tracking process
- Monitoring logistics
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Bioproduction
- Scale-Up
- Non-GMP pilot batch
- GMP batch
- CGMP
- Deviations
- Quality control
- CMC
- GLP compliance
- for preclinical NCS (non-clinical safety) studies
- viral safety testing
- GMP compliance
- 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
- Formulation
- Formulation
- Adjuvants
- Fill & finish
- Prefilled syringe
- Vaccine shipment and distribution
- Storage matter
- Labelling
- Packaging for shipping
- Instruction Label
- Cold chain logistics
- Quality control & analytical process monitoring
- Stability Assessment
- 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
