CONSULTING

CONSULTING

CONSULTING

Regulatory

Regulatory

Regulatory

Stay informed & collaborate

Stay informed & collaborate

Stay informed & collaborate

Our dedicated Regulatory team continuously monitors industry updates, guidelines, and standards to ensure we remain at the forefront of regulatory changes that may impact our clients' operations.

Our dedicated Regulatory team continuously monitors industry updates, guidelines, and standards to ensure we remain at the forefront of regulatory changes that may impact our clients' operations.

Our dedicated Regulatory team continuously monitors industry updates, guidelines, and standards to ensure we remain at the forefront of regulatory changes that may impact our clients' operations.

Our regulatory team tailors its services to meet your specific needs, providing assistance in the preparation of Investigational Medicinal Product (IMP) and Investigational New Drug (IND) dossiers for Clinical Trial Applications.
We can guide you through the entire process, including supporting Q&A sessions with health authorities to ensure prompt and adaptive responses to their inquiries.

Our regulatory team tailors its services to meet your specific needs, providing assistance in the preparation of Investigational Medicinal Product (IMP) and Investigational New Drug (IND) dossiers for Clinical Trial Applications.
We can guide you through the entire process, including supporting Q&A sessions with health authorities to ensure prompt and adaptive responses to their inquiries.

Our regulatory team tailors its services to meet your specific needs, providing assistance in the preparation of Investigational Medicinal Product (IMP) and Investigational New Drug (IND) dossiers for Clinical Trial Applications.
We can guide you through the entire process, including supporting Q&A sessions with health authorities to ensure prompt and adaptive responses to their inquiries.

Our Scope of Work

Our Scope of Work

Our Scope of Work

Preparation of briefing books

Preparation of briefing books

Preparation of briefing books

Dedicated to pre-submission meetings.

Dedicated to pre-submission meetings.

Dedicated to pre-submission meetings.

Support of development teams

Support of development teams

Support of development teams

Identify key issues and participate in regulatory discussions, facilitating Scientific Advice in Europe or Pre-IND meetings with the FDA in the US.

Identify key issues and participate in regulatory discussions, facilitating Scientific Advice in Europe or Pre-IND meetings with the FDA in the US.

Identify key issues and participate in regulatory discussions, facilitating Scientific Advice in Europe or Pre-IND meetings with the FDA in the US.

Comprehensive support in IMPD and IND writing, review or update

Comprehensive support in IMPD and IND writing, review or update

Comprehensive support in IMPD and IND writing, review or update

Providing technical, quality and Module 3 dossier preparation for clinical trial applications.

Providing technical, quality and Module 3 dossier preparation for clinical trial applications.

Providing technical, quality and Module 3 dossier preparation for clinical trial applications.

Advise, prepare, and represent clients at health authority meetings

Advise, prepare, and represent clients at health authority meetings

Advise, prepare, and represent clients at health authority meetings

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.

Navigating the regulatory landscape

Navigating the regulatory landscape

Navigating the regulatory landscape

In Europe, the US and regions such as the UK, adapting to changing guidelines and harmonizing responses across different regulatory bodies.

In Europe, the US and regions such as the UK, adapting to changing guidelines and harmonizing responses across different regulatory bodies.

In Europe, the US and regions such as the UK, adapting to changing guidelines and harmonizing responses across different regulatory bodies.

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