We are excited to welcome Vici Health Sciences to the Contract Laboratory – The Laboratory Outsourcing Network, enhancing our collective strength in pharmaceutical research, development, and manufacturing. As a specialized contract development and manufacturing organization (CDMO), Vici Health Sciences provides an extensive array of services critical to accelerating drug development and achieving regulatory compliance.
About Vici Health Sciences
Headquartered in Elkridge, Maryland, Vici Health Sciences is focused on delivering end-to-end solutions for pharmaceutical companies. Their expert team provides comprehensive support, from early formulation development through clinical trials and regulatory filings, effectively streamlining the path to market for emerging therapies.
Comprehensive Services Offered
Formulation Development
Vici Health Sciences excels in developing versatile formulations, including oral solids, liquids, topical creams and gels, injectable solutions, ophthalmic preparations, and buccal drug delivery systems. Their formulation expertise includes bioavailability enhancement strategies, such as particle size reduction, solid dispersions, cyclodextrin complexes, and lipid-based delivery systems, ensuring optimal therapeutic outcomes.
Analytical Testing
With robust analytical capabilities, Vici offers extensive testing services including method development and validation, identification and assay analysis, impurity profiling, dissolution testing, content uniformity, stability testing, and shelf-life studies. Their commitment to accuracy and compliance ensures product integrity and regulatory readiness.
Manufacturing Services
This CDMO provides diverse manufacturing services, including clinical supply management, custom synthesis under current Good Manufacturing Practices (cGMP), clinical supply manufacturing, clinical packaging, and nutraceutical/dietary supplement production. Their manufacturing processes strictly adhere to FDA guidelines, ensuring high-quality outcomes for clinical and commercial products.
Regulatory Services
Expert regulatory guidance is integral to Vici’s offering, encompassing pre-IND, IND, NDA, and ANDA submissions. They also specialize in IND-enabling studies, ANDA filing, post-approval regulatory management, and strategic consulting for 505(b)(2) applications, ensuring a seamless regulatory approval process.
Chemistry, Manufacturing, and Controls (CMC) Consulting
Vici Health Sciences provides specialized CMC consulting, including technology transfer to Contract Manufacturing Organizations (CMOs), troubleshooting manufacturing processes, nitrosamine impurities remediation, pharmaceutical patent support, and technical due diligence. These services are crucial for companies aiming to optimize manufacturing processes and ensure regulatory compliance.
Why Partner with Vici Health Sciences?
Partnering with Vici Health Sciences provides significant strategic advantages, including extensive industry expertise, proven regulatory success, and comprehensive project support. Their team has developed over 50 formulations and participated in more than 30 clinical trials, highlighting their vast experience and capabilities. Additionally, Vici has successfully secured FDA approvals for over 15 Abbreviated New Drug Applications (ANDAs), underscoring their regulatory expertise.
Connect with Vici Health Sciences today to leverage their expertise in accelerating your pharmaceutical development projects. Submit your test request right away—it’s quick and free!
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