CONSULTING

CONSULTING

CONSULTING

Quality Assurance

Quality Assurance

Quality Assurance

Our track record

Our track record

Our track record

Our auditors are senior professionals with over 300 audits under their belts, ensuring strict compliance and expertise in navigating regulatory requirement.

Our auditors are senior professionals with over 300 audits under their belts, ensuring strict compliance and expertise in navigating regulatory requirement.

Our auditors are senior professionals with over 300 audits under their belts, ensuring strict compliance and expertise in navigating regulatory requirement.

Our QA team offer comprehensive assistance in setting up Quality Management Systems (QMS) and audit tailored to your specific needs. Through meticulous QMS process definition, precise sizing, and seamless implementation, we ensure the highest standards in our QA activities.

Our QA team offer comprehensive assistance in setting up Quality Management Systems (QMS) and audit tailored to your specific needs. Through meticulous QMS process definition, precise sizing, and seamless implementation, we ensure the highest standards in our QA activities.

Our QA team offer comprehensive assistance in setting up Quality Management Systems (QMS) and audit tailored to your specific needs. Through meticulous QMS process definition, precise sizing, and seamless implementation, we ensure the highest standards in our QA activities.

Our Scope of Work

Our Scope of Work

Our Scope of Work

Audits

Audits

Audits

We conduct audits internationally and CAPA following, covering all the supply chain of your product such as:

• Cell Bank Manufacturing and storage
• Biological or non-biological Drug Substance manufacturing and Control
• Sterile or non-sterile Drug Product manufacturing and control
• Clinical labelling and packaging
• Final release of your clinical product

We conduct audits internationally and CAPA following, covering all the supply chain of your product such as:

• Cell Bank Manufacturing and storage
• Biological or non-biological Drug Substance manufacturing and Control
• Sterile or non-sterile Drug Product manufacturing and control
• Clinical labelling and packaging
• Final release of your clinical product

We conduct audits internationally and CAPA following, covering all the supply chain of your product such as:

• Cell Bank Manufacturing and storage
• Biological or non-biological Drug Substance manufacturing and Control
• Sterile or non-sterile Drug Product manufacturing and control
• Clinical labelling and packaging
• Final release of your clinical product

Training

Training

Training

Tailoring IMP requirements based on clinical trial protocols and CMC constraints such as product expiration, storage conditions, temperature monitoring, customs regulations, and CMO standards.

Tailoring IMP requirements based on clinical trial protocols and CMC constraints such as product expiration, storage conditions, temperature monitoring, customs regulations, and CMO standards.

Tailoring IMP requirements based on clinical trial protocols and CMC constraints such as product expiration, storage conditions, temperature monitoring, customs regulations, and CMO standards.

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