Integrated Drug Formulation Services

Integrated Drug Formulation Services at US Specialty Formulations (USSF)

Integrated Drug Formulation Services
USSF does formulation development and optimization to get your drug to the market—once you’ve developed the molecule.
If you’ve got a compound ready, we help turn it into a usable drug. Our specialty is injectable formulations: stabilizing the molecule, getting it into solution, and ensuring shelf life and performance meet your labeled regulatory filing. We also offer oral formulations—by way of our QYNDR platform – (to learn more, go to – QYNDR – A Kinder way to vaccinate).
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Integrated Drug Formulation Services

What We Formulate

Sterile Injectables

Sterile Injectables

  • We transform your active pharmaceutical ingredient (API) into a stable, sterile injectable—liquid or lyophilized—ready for clinical or commercial use. Our team focuses on solubility, stability, and compatibility to ensure the final product meets therapeutic and regulatory goals.
QYNDR Oral Dosage Formats

QYNDR Oral Dosage Formats

  • For oral drugs and biologics, we work through our QYNDR platform, which supports oral dosage formats with controlled, sustained, or immediate release profiles.

Analytical & Quality Support

Once we’ve formulated your drug we back it with full analytical testing:
botanical-solution

Pre-Formulation Analysis

API characteristics to inform formulation strategy
saline solution

Excipient Compatibility

Selecting excipients that support stability and performance
vials

Stability Studies

Accelerated and long-term testing to confirm shelf life
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Impurity Profiling

Identifying and quantifying impurities
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Method Development Validation

Building and validating analytical methods that meet regulatory standards

Regulatory & Manufacturing Support

We help to accelerate moving from formulation to approval:

Regulatory Filings

Regulatory Filings

  • IND, NDA, ANDA support
CMC Compliance

CMC Compliance

  • Chemistry, Manufacturing & Controls documentation
Audit Prep

Audit Prep

  • Training and readiness for FDA and EMA inspections
cGMP Manufacturing

cGMP Manufacturing

  • Clinical and commercial batch production in our compliant facilities

Why Work with USSF?

You’ve done the hard part—now let us take it from here. At USSF, we specialize in transforming your developed molecule into a finished drug product. Whether it’s an injectable or an oral dosage formats (with QYNDR), we handle the formulation, stabilization, and manufacturing with speed, precision, and full regulatory alignment.
Bringing your molecule to market