Government Contracting - Biopharmaceutical Product Development
We work with biotechnology partners to bring biodefense and infectious disease medical countermeasures into advanced development for U.S. Government clients.
Do you have an Animal Rule strategy? Could you list the additional requirements for human clinical trials funded by U.S. government agencies? Would you pass a DoD quality audit? Just want to focus on the technical details? We can help.
Your regulatory strategy is key for both technical and program integration. DynPort can help you develop regulatory strategies to support product licensure in the U.S., including assisting with Investigational New Drug (IND) applications and chemistry, manufacturing and control (CMC) development in common technical document (CTD) format. We can help you prepare for crucial U.S. Food and Drug Administration (FDA) meetings, and maintain the life cycle of IND applications.
Complete quality nonclinical studies on schedule and within cost. Our PMP-certified scientists apply professional project management tools and extensive experience in GLP compliance to ensure success. Benefit from our experience in the development and management of nonclinical strategies ranging from IND-enabling toxicology studies to demonstration of efficacy according to the FDA Animal Rule. Our scientists have experience with numerous infectious diseases including botulism, plague, tularemia, smallpox, anthrax, alphaviruses and filoviruses.
Clinical Research and Clinical Operations
Need help taking an early-stage product into the clinic? DynPort has advanced 8 products into clinical trials in the last 10 years; our clinical team has experience with Phase 1 through 4 trials. We offer expertise in specialized clinical procedures for regulatory requirements under the Common Rule (including the FDA Animal Rule), and can help you design and manage a successful clinical development strategy within government contracting guidelines. While we specialize in vaccine development, we can also help with drug development at any stage.
Manufacturing, Testing and Technical Support
DynPort can help design compliant manufacturing strategies using scalable manufacturing processes for various stages of clinical trials. Our experts can assist with tech transfer, development and validation of lot release and stability methods, product stability programs, reference standards, or critical reagent programs, including cell banks, challenge materials and product-specific assays.
Quality can never be tested in to your final product; it must be built in. DynPort can help you understand regulations for engaging in research involving human subjects when supported by a Federal agency, and prepare for CGMP, GLP and GCP regulatory compliance inspections.