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

Bringing expertise
and agility to biotech companies.

© 2024 INITS. All rights reserved

Bringing expertise and agility to biotech companies.

© 2024 INITS. All rights reserved