Our integrated approach ensures data generated in the lab is directly aligned with regulatory expectations, accelerating program progression without costly rework.
Medical Countermeasures
Our Mission to Protect the Warfighter with Effective Medical Countermeasures
At CMC Pharma, our mission is to advance the development and delivery of medical countermeasures that protect civilians and military personnel from chemical, biological, radiological, and nuclear (CBRN) threats. We achieve this by:
- Collaborating with Government and Industry: Partnering with agencies like the Department of Defense (DoD), Biomedical Advanced Research and Development Authority (BARDA), and other stakeholders to identify and develop new countermeasures.
- Innovating Therapies: Developing new formulations, including repurposed, multipe-API, and controlled-release systems, and modernizing existing therapies to improve efficacy and shelf life.
- Ensuring Readiness: Providing manufacturing oversight and regulatory support to accelerate development programs, ensuring therapies are available and effective when needed.
Government Partnerships & Consortium Involvement
- CMC Pharma is an active participant in multiple government and industry initiatives, including:
- Medical CBRN Defense Consortium (MCDC)
- Biopharmaceutical Manufacturing Preparedness Consortium (BioMap)
- Rapid Response Partnership Vehicle (RRPV)
Our work with these consortia, along with multiple DoD contracts—both as a prime and subcontractor—demonstrates our ability to collaborate effectively across public and private sectors to identify and advance new countermeasures.
By partnering with CMC, government and industry teams can leverage our scientific, operational, and regulatory expertise to accelerate programs that improve survivability, reduce logistical burden, and extend the shelf life of critical therapies.
Comprehensive MCM Development Services
CMC Pharma supports MCM programs at every stage of development, from feasibility through commercialization:
Optimize drug products for stability, controlled release, and delivery efficiency.
01
Prototype Preparation (RAMP)
Rapid production of non-GMP prototypes for in vitro and in vivo evaluation. Quickly evaluate feasibility.
02
Analytical Method Development, Execution, & Validation
Ensure compliance with regulatory requirements.
03
ICH Stability & Compatibility Studies
Extend shelf life and ensure readiness under routine and custom storage conditions.
04
Manufacturing Enablement & Oversight
Scale-up, tech transfer, and CMO management to deliver compliant, reliable production.
05
Integrated Regulatory Support
Guidance for IND, NDA, and other submission pathways.
06
Specialized Expertise for High-Impact Threats
- CMC Pharma’s MCM capabilities are designed to meet the unique challenges of critical national security and public health programs:
- Shelf Life Extension & Modernization: Programs aimed at increasing product longevity and reliability for emergency use, improving the logistics of MCM deployment.
- New Therapy Development: Multiple API formulations, NCE development, and controlled-release formulations strategies to optimize efficacy and logistics.
- Rapid Scale-Up & GMP Oversight: Ensuring that therapies developed in the lab are efficiently transferred to compliant manufacturing partners.
- Government Compliance: Our accounting systems are government-approved, and we are actively working toward CMMC Level 2 compliance, demonstrating readiness for sensitive and secure program execution.
Why CMC Pharma is a Unique MCM Partner
CMC Pharma differentiates itself by collaborating with both industry and government partners and can collaborate as both a prime and subcontractor, providing
- End-to-End Expertise: From RAMP prototypes to IND/NDA-ready data and full-scale GMP manufacturing oversight.
- Public-Private Collaboration: Experience partnering with industry, consortia, DoD, BARDA, and other government agencies.
- Regulatory Integration: Data generated in our labs is submission-ready, ensuring alignment with government and FDA requirements.
- Rapid, Flexible Execution: Our team is nimble and delivers quickly, avoiding the bottlenecks often encountered at larger CDMOs
This approach ensures that MCM programs progress efficiently, safely, and strategically, giving the government and industry partners confidence that their therapies will be ready when needed.
CMC Pharma is committed to advancing medical countermeasures that protect civilians and warfighters, reduce logistical burden, and modernize critical therapies. By integrating development, manufacturing, and regulatory guidance, we provide a single, trusted partner for complex, high-stakes programs. Partner with us to de-risk MCM programs, accelerate timelines, and deliver solutions that enhance readiness and survivability.
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Contact Us Today and find out how CMC Pharma can help you!
Whether you need to develop robust analytical methods or require routine testing. Contact CMC Pharma to learn how we can help you advance your development program.
Send us a message or give us a call at 440-485-1734.
