Drug Product Development Clients

CMC Pharma provides chemical and technical expertise to a variety of clients in the pharmaceutical and biotech industries and US government agencies.

We have experience with a wide range of projects and dosage forms and have successfully led efforts to comply with the FDA’s requirements on formulation development, analytical development, and process development and control. CMC Pharma is ready to assist clients ranging from non-profit research institutions and pharmaceutical start-ups to government drug development programs as a prime or subcontractor.

An Experienced Partner for Government Contracts

CMC Pharma is a leading contract laboratory services company, focused on providing drug product development services including formulation development, drug delivery system design, analytical development, manufacturing process development, and stability services to the federal government. Our mission is to deliver our specialized expertise to government drug development programs, resulting in advancement of better drug product candidates.

We Are a Valued Resource to Commercial Clients, Including:

Start-ups & emerging companies
Established pharmaceutical & biotechnology companies
Virtual drug development companies
Non-profit research institutions
Partners requiring CMC-focused subcontractors for government contracts

How We Assist Your Drug Product Development Needs:

Early to Late Stage Programs

Determining appropriate CMC development strategy
Identifying & developing drug delivery systems (i.e. long-acting formulations)
Completing appropriate formulation development studies
Designing & executing stability programs

Through Post-Approval

Formulation & process remediation
Identifying formulation stabilizing strategies
Developing & validating analytical methods
Determining CQAs & CPPs and implementing proper control strategy
Leading & assisting OOS and OOT investigations
Determining product shelf-lives
Troubleshooting stability failures
Validation of processes, methods, and equipment

cGMP Lab Services

Analytical development
Analytical method validation
Release testing
ICH compliant stability
Material compatibility

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Extensive Government Contract Experience

CMC Pharma has developed significant expertise in developing medical countermeasures. Leveraging our significant injectable and oral drug product development and manufacturing experience, we strive to identify, develop and manufacture new chemical entities and reformulate and/or repurpose drugs for government programs.

CMC Pharma has prepared proposals and executed contracts for a variety of projects and has the necessary technical experience and corporate infrastructure to execute Government Grants & Contracts.

We are an active member of the Medical CBRN Defense Consortium (https://www.medcbrn.org/)

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What CMC Services Do You Require & How Can We Help?

Contact Us Today and find out how CMC Pharma can help you!

We offer drug product development services to the pharmaceutical industry and support federally funded programs. Find out how CMC Pharma can help solve a medical need.

Send us a message or give us a call at 440-485-1734

Our Focus Areas Include:

Analytical Chemistry

Drug Delivery Systems

Stability Evaluations

Formulation Development

cGMP Lab Services

Prototype Preparation

We are experts with a variety of drug classes including small molecules, potent compounds, beta-lactams, cytotoxics, hormones, low-solubility drugs, and unstable drugs.

Pharmaceutical Development Clients

CMC Pharma provides chemical and technical expertise to a variety of clients in the pharmaceutical and biotech industries and US government agencies.

An Experienced Partner for Government Contracts

We Are a Valued Resource to Commercial Clients, Including:

Extensive Government Contract Experience

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