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Clinical Development

Accelerate Your Path
to Clinical Trials

From Phase 0 to Phase III, we deliver rapid to clinic solutions backed by our formulation expertise and manufacturing excellence.

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Challenges We Solve

Having worked on both the CDMO and sponsor side, we understand the challenges of advancing clinical programs firsthand. Forma was built to help clients navigate those challenges through a collaborative, science-driven, and practical approach focused on keeping programs on track.

Our Solutions

Industry-leading platforms to overcome your most challenging formulation obstacles

Equipment Capability

State-of-the-art manufacturing equipment designed for flexibility and precision in clinical-scale production.

  • Spray Dried Dispersion (Anhydro Suite)
  • Hot Melt Extrusion (Leistritiz Suite)
  • Granulation (Fluid Bed, High-Shear, Dry)
  • Compression (Korsch Suite)
  • Encapsulation (Planeta Suite)
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Spray Dryer Highlight
MS150

Industry-leading platforms to overcome your most challenging formulation obstacles

Early insight to guide successful development

  • In-depth physicochemical analysis to better understand solubility, stability, and potential development risks.

  • Rapid assessment of formulation strategies and delivery technologies to identify the best-fit approach early.

  • A practical, science-driven roadmap designed to guide programs from discovery through clinical development with confidence.

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Engineering optimized formulations for clinical success

  • Advanced technologies, including spray-dried dispersions and hot melt extrusion, to solve complex formulation challenges.

  • Data-driven testing to improve bioavailability and ensure consistent performance.

  • Scalable formulations designed for smooth transition from development to manufacturing.

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Reliable GMP manufacturing for clinical trials

  • GMP manufacturing designed to support clinical programs with speed and reliability.

  • Proven quality systems focused on consistency, safety, and traceability.

  • Flexible production and packaging capabilities to support global clinical trial needs.

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Case Examples

Expert perspectives on formulation science, manufacturing technologies, 
and the evolving challenges of oral drug development.

  • Modified Release Fixed-Dose Combination

    Challenge

    Reduce patient pill burden while maintaining bioequivalence and release performance.

    Solution

    Developed a complex coating strategy to combine two active ingredients into a single modified release capsule.

    Result

    Successfully achieved bioequivalence while reducing pill burden with a scalable formulation approach.

  • 6-Month Tech Transfer of Commercial Program

    Challenge

    Client needed to transition to a new manufacturing partner to maintain commercial supply continuity.

    Solution

    Executed an accelerated tech transfer including feasibility studies, analytical method transfer, process validation, and commercial readiness activities.

    Result

    Successfully maintained uninterrupted product supply with high-quality execution and no process deviations.

  • Phase III, Registration, PV & Commercialization

    Challenge

    Advance a Phase III program to commercial manufacturing within an accelerated timeline.

    Solution

    Provided end-to-end technical support, process validation, and long-term scientific collaboration to support registration and commercialization readiness.

    Result

    Successfully guided the program from clinical development through commercial launch with a scalable and reliable manufacturing approach.

  • Formulating Oral Peptide Solutions

    Challenge

    Develop a novel formulation capable of protecting peptide molecules through the GI tract while enabling effective oral delivery.

    Solution

    Designed an innovative formulation approach to enhance peptide bioavailability for a class not previously commercialized as an oral dosage form.

    Result

    Advanced a new frontier in oral biologics by enabling peptide delivery through a patient-friendly oral formulation approach.

  • 2-Month Minitablet DOE Study

    Challenge

    Execute a complex minitablet DOE study under an accelerated timeline after previous tooling issues at another CDMO.

    Solution

    Leveraged internal expertise and rapid problem-solving to successfully develop and manufacture batches on the first run.

    Result

    Successfully completed the study to support regulatory filing timelines and program progression.