About Us
Our Approach
Our Expertise
Our Expertise
At Vistirna, we take a holistic approach to consulting. We work closely with our clients to understand their goals and challenges and develop solutions that address their specific needs. Our approach is collaborative, transparent, and results-driven.
Our Expertise
Our Expertise
Our Expertise
At Vistirna, we have years of experience in consulting services. We specialize in providing top-notch drug development, regulatory strategy, and CMC support services. Our expertise can help take your business to the next product development and commercialization level.
Our Team
Our Expertise
Our Clients
Our team at Vistirna is made up of highly skilled professionals with diverse backgrounds. We work together to provide our clients with tailored solutions that meet their unique needs. Meet our team and learn more about our areas of expertise.
Our Clients
Our Expertise
Our Clients
Vistirna team has had the privilege of working with a wide range of clients across biopharma industries. From startups to established corporations, we have helped businesses of all sizes achieve their goals.
Our Services
Nonclinical
Regulatory
Nonclinical
Nonclinical CRO selection and oversight
Management of safety assessment (nonclinical pharmacology and toxicology) studies of biologics and small molecules at CRO
Review of CRO protocols and reports for regulatory submissions
Development and review of nonclinical overviews
CMC
Regulatory
Nonclinical
Development and review of eCTD-compliant Module 3 CMC for IND, NDA, BLA, and MF submissions for biologics and small molecules drug substances and drug products
Subject matter expertise in the development (formulation, process, and analytical) and GMP manufacturing of small molecule and biologics drug substances and drug products
Selection
Development and review of eCTD-compliant Module 3 CMC for IND, NDA, BLA, and MF submissions for biologics and small molecules drug substances and drug products
Subject matter expertise in the development (formulation, process, and analytical) and GMP manufacturing of small molecule and biologics drug substances and drug products
Selection and oversight of CDMO for biologics and small molecule drug substance and drug product development and manufacturing
Regulatory
Regulatory
Regulatory
Create or assist with the refinement of regulatory strategy
Development and review of pre-IND briefing documents
Organize and participate in the pre-IND meetings with the FDA
Review and submission of IND applications
Communicate with the regulatory
agencies