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
© 2024 INITS. All rights reserved
© 2024 INITS. All rights reserved
© 2024 INITS. All rights reserved