,Clinical and Non-Clinical Consulting and Strategic Services- Overview
Our experienced team at Freyr assists with scientific and Regulatory reviews, ensuring consistency and accuracy in documentation to meet deadlines without errors.
Our clinical and non-clinical experts, including toxicologists and physicians, review development plans for both clinical and non-clinical studies to ensure Regulatory compliance. We help you curate robust development strategies with alternate plans to mitigate risks, providing cost and time efficiency for innovative product categories, which include but are not limited to NCEs, NBEs, 505(b)(2), and biosimilars.
Additionally, Freyr has a team of experienced scientists and QA assurance professionals with hands-on experience conducting GLP audits. Our scientists and auditors also conduct independent evaluations of test facilities, ensuring compliance and providing comprehensive audit reports.
Our Clinical and Non-Clinical Consulting and Strategic services include:
- Clinical writing consulting and strategic services
- Technical writing support for GxP compliance
- Business process optimization
- Scientific and Regulatory review of non-clinical documents
- Development and review of study plans and protocols
- Non-Clinical development strategy
- Consultation on non-clinical issues
- Consultation and responses to Regulatory queries
- GLP audits of test facilities
Freyr’s Clinical and Non-Clinical Consulting and Strategic Services
Clinical and Non-Clinical Consulting and Strategic Services
- Highly experienced clinical and non-clinical teams led by industry leaders with decades of experience
- Scientists with hands-on experience in clinical and non-clinical domains
- Experience in handling projects from discovery to the clinical stage
- Experience in handling complex programs involving highly innovative products and diversified therapeutic areas
- Strategic inputs in appropriate decision-making
- Experience in dealing with Regulatory authorities’ queries globally
- Fast turnaround time
- One-stop solution for clinical and non-clinical Regulatory issues
- Inter-disciplinary collaboration (CMC, clinical, and non-clinical) to ensure smooth project movement and success
- Accessibility of experts and on-priority services
- Customized services depending on specific needs
