Nonclinical studies approved by U.S. Army Medical Research and Development Command
Clinical trials completed
Proven success in product development and licensure.
Government agencies - can depend on DVC to successfully manage large, complex medical countermeasure development government contracts.
Biotech and pharmaceutical companies - can rely on DVC for experienced program management and guidance through the complex government contracting process.
Biodefense colleagues - can look to DVC for regulatory and nonclinical strategy and support for FDA animal rule submissions.
Service providers - can register to be notified of upcoming opportunities to support our research and clinical trials or contact us to discuss possibilities.
Commercial companies - with products for infectious disease indications nearing Phase 1 clinical trials can rely on our NIAID-sponsored Phase 1 Clinical Trial Unit.
Delivering medical and program expertise.
Expertise providing clinical research services and product development life cycles for vaccines and therapeutic products including those for influenza, plague and botulinum vaccines, anti-infective products and treatments for nerve agent exposure.
Process Development and Manufacturing
Manufacturing and technical asset management across a broad range of biologic processing methodologies and technical oversight for the product lifespan, including advanced development and licensure.
Developed successful strategy and submissions to move six biodefense products into clinical development and one to licensure. Team provides insight into regulatory requirements and compiled compliant dossiers for regulatory filings.
Oversight of activities to ensure compliance with regulatory guidelines and contractual requirements. Product, Clinical, and Nonclinical quality assurance experts also provide control of electronic records.
Compliance and Authorization
DVC systems and processes meet or exceed government contracting requirements including those for the Defense Contract Audit Agency (DCAA), Defense Contract Management Agency (DCMA), and International Traffic in Arms Regulations (ITAR). DVC also has a validated electronic document management system and earned value management system.
Analytical Test Development
Scientists and biostatisticians support statistical approaches and analyses of complex data sets to develop and validate assays, and establish correlates of protective vaccine-induced immunity and product efficacy for licensure.
Comprehensive experience providing oversight of animal testing work at multiple subcontractor sites with a team of advanced degreed employees who support the development of biologics including vaccines, therapeutics, and alternative vaccine delivery systems.
DVC has experience managing complex biopharmaceutical product development programs. Certified Program Management Professionals drive continual engagement across program teams and focus on meeting customer expectations.
Partner with DVC.
We are actively seeking technology partners for medical countermeasure development opportunities. DVC can also team with you for Other Transaction Authority (OTA) agreements with the Department of Defense as a member of the Medical Technology Enterprise Consortium (MTEC) and Medical CBRN Defense Consortium (MCDC).