CONSULTING
CONSULTING
CONSULTING
CMC (Chemistry, Manufacturing & Controls)
CMC (Chemistry, Manufacturing & Controls)
CMC (Chemistry, Manufacturing & Controls)
Team specialization
Team specialization
Team specialization
Process development
Process development
Process development
Process validation
Process validation
Process validation
Analytical development
Analytical development
Analytical development
Drug substance
Drug substance
Drug substance
Analytical validation
Analytical validation
Analytical validation
Drug product
Drug product
Drug product
Product release & characterization
Product release & characterization
Product release & characterization
Our team of experts is specialized in various critical areas to support your product development, especially for biological products (mAbs, cell and gene therapy products, exosomes...). We work with biotech companies at various stages of their projects: starting from early phases to Phase 3 and marketing authorisation application preparation.
Our team of experts is specialized in various critical areas to support your product development, especially for biological products (mAbs, cell and gene therapy products, exosomes...). We work with biotech companies at various stages of their projects: starting from early phases to Phase 3 and marketing authorisation application preparation.
Our team of experts is specialized in various critical areas to support your product development, especially for biological products (mAbs, cell and gene therapy products, exosomes...). We work with biotech companies at various stages of their projects: starting from early phases to Phase 3 and marketing authorisation application preparation.
Our Scope of Work
Our Scope of Work
Our Scope of Work
Global development strategy
Global development strategy
Global development strategy
Early-stage strategy: process development, clinical batches, stability studies, planning, budget…
Late-stage strategy: comparability, process validation...
Early-stage strategy: process development, clinical batches, stability studies, planning, budget…
Late-stage strategy: comparability, process validation...
Early-stage strategy: process development, clinical batches, stability studies, planning, budget…
Late-stage strategy: comparability, process validation...
CMO/CDMO selection
CMO/CDMO selection
CMO/CDMO selection
Using structured frameworks and evaluation tools, assisting in Request for Proposal (RFP) creation and follow-up.
Using structured frameworks and evaluation tools, assisting in Request for Proposal (RFP) creation and follow-up.
Using structured frameworks and evaluation tools, assisting in Request for Proposal (RFP) creation and follow-up.
Project management
Project management
Project management
Acting as CMC project manager for our client: process and analytical methods development and /or transfer, production, testing and quality event follow-up.
Acting as CMC project manager for our client: process and analytical methods development and /or transfer, production, testing and quality event follow-up.
Acting as CMC project manager for our client: process and analytical methods development and /or transfer, production, testing and quality event follow-up.
CMC engineering & technical support
CMC engineering & technical support
CMC engineering & technical support
Providing technical support to clients with in-house labs, offering guidance on upstream and downstream processes.
Providing technical support to clients with in-house labs, offering guidance on upstream and downstream processes.
Providing technical support to clients with in-house labs, offering guidance on upstream and downstream processes.
Validation Plan
Validation Plan
Validation Plan
Creation of accurate plans to ensure process validation, reproducibility and adherence to regulatory standards.
Creation of accurate plans to ensure process validation, reproducibility and adherence to regulatory standards.
Creation of accurate plans to ensure process validation, reproducibility and adherence to regulatory standards.
Our team uses
Our team uses
Our team uses
For inquiries or to explore how our services can benefit your specific needs
For inquiries or to explore how our services can benefit your specific needs
For inquiries or to explore how our services can benefit your specific needs
© 2024 INITS. All rights reserved
© 2024 INITS. All rights reserved
© 2024 INITS. All rights reserved