Expertise
Advancing Drug Development Across Key Expertise Areas
CMC Pharma is a full-service drug development partner, delivering integrated solutions from discovery through commercialization. Our business model is unique and sets us apart from other CDMOs – we are much more flexible, with tailored solutions that aren’t limited by dosage form. Plus, unlike typical testing labs or isolated consultants, our model embeds regulatory guidance, manufacturing enablement, and project oversight into every stage of development.
Our expertise spans the full spectrum of small molecule drug development, specialized dosage forms, and critical medical countermeasures. By combining scientific rigor, operational flexibility, and regulatory foresight, we de-risk programs, accelerate timelines, and provide submission-ready data for INDs, NDAs, and global filings.
Small Molecules
Small molecules remain the backbone of modern therapeutics, representing the majority of FDA-approved drugs. CMC Pharma focuses on efficient, regulatory-aligned development of small molecule programs.
- Integrated Lab Services: Formulation, analytical method development, execution, and validation, stability testing, and process development.
- Manufacturing Enablement: Prototype preparation (RAMP), scale-up, tech transfer, and CMO oversight.
- Regulatory Integration: CMC strategy and execution, IND/NDA preparation and submission-ready data.
- Therapeutic Areas: Oncology, cardiovascular, CNS/mental health, endocrinology/metabolic diseases, orthopedic/anti-inflammatory, infectious diseases/immunology, animal health, and more.
Our full-service model ensures speed, quality, and cost-effectiveness, keeping small molecule programs on track from early discovery through commercialization.
Traditional Dosage Forms
- Regulatory & Compliance Focus: Robust methods, stability studies, and documentation aligned with FDA and ICH standards.
- Integrated Manufacturing Enablement: RAMP prototypes, scale-up, and GMP oversight to ensure smooth tech transfer.
- Special Considerations: Proper handling and compliance for controlled substances (Schedules II–IV).
Our integrated approach reduces rework, minimizes delays, and ensures programs are ready for regulatory submission.
Novel & Complex Dosage Forms
CMC Pharma supports advanced delivery systems, including long-acting injectables, controlled release formulations, and solubilized or suspended drug products.
- Lab Services: Formulation development, analytical method validation, and stability testing designed for complex systems.
- Manufacturing Enablement: Prototype preparation, scale-up, and CMO oversight tailored for advanced dosage forms.
- Regulatory Guidance: Submission-ready data aligned with FDA, ICH, and government requirements.
This expertise enables clients to accelerate innovative therapies while minimizing risk, bridging the gap between scientific innovation and commercial feasibility.
Controlled Substances (Schedules II–IV)
- CMC Pharma is licensed and experienced to develop controlled substances safely and effectively.
- Expert Handling & Compliance: Ensuring security, regulatory adherence, and safe laboratory practices.
- Integrated Development & Regulatory Oversight: Seamless alignment of lab results with submission-ready documentation.
- Manufacturing Enablement: RAMP prototypes and GMP oversight for scalable production.
Highly Potent Compounds (HPAPIs)
CMC Pharma has specialized expertise with oncology, hormone, and other highly potent compounds. These molecules require specialized containment, handling, and expertise due to safety and regulatory considerations.
- Integrated Lab Development: Formulation, analytical, and stability studies with HPAPI containment.
- Manufacturing Oversight: Safe scale-up, tech transfer, and CMO management.
- Regulatory & Compliance Alignment: Submission-ready data addressing FDA, ICH, and government expectations.
Medical Countermeasures
- CMC Pharma is a trusted partner for government and industry MCM programs, dedicated to protecting the warfighter and civilians from CBRN (chemical, biological, and radiological, and Nuclear) threats:
- Government Partnerships: Successful Government contracts (prime and subcontractor), and Consortia Membership: MCDC, BioMapp,, RRPV.
- Rapid Prototype Development & Scale-Up: RAMP Prototypes, controlled-release therapies, stability enhancement, and GMP oversight.
- Regulatory & Project Management: IND/NDA-ready data, proposal/grant writing, and program management for complex, high-stakes projects.
- Specialized Capabilities: Shelf-life extension, therapy modernization, and secure handling compliant with CMMC and government-approved accounting standards.
CMC Pharma’s experience writing successful proposals, executing complex programs, and maintaining government trust positions us uniquely in the MCM landscape.
The CMC Difference
- Across all areas of expertise, CMC Pharma delivers:
- End-to-End Solutions: Lab development, RAMP Production, manufacturing enablement, and integrated regulatory support.
- Speed & Agility: Nimbleness and tailored approach prevents delays common in larger CDMOs.
- Cost-Effectiveness: Single partner model means fewer vendors, reduced hand-offs, and submission-ready data to reduce overall program cost.
- Regulatory Integration: Every experiment and batch is aligned with FDA, ICH, and government standards.
- Trusted Partnership: We act as an extension of your team, anticipating challenges and solving them proactively to de-risk programs and accelerate timelines.
Partner with CMC Pharma to advance small molecules, traditional and novel dosage forms, controlled substances, HPAPIs, and medical countermeasures, and more. Our integrated, full-service approach ensures programs are efficient, compliant, and positioned for success.
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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