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.

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 compatability

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/)

img3

    Your Name*

    Your Email*

    Phone Number

    Company/Title*

    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:

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