Long-Acting Success
Identified multiple long-acting formulations meeting the client’s target product profile and ready for preclinical evaluation.
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Case Studies
Every program we support is designed for one outcome:
To Move Your Product Forward To Approval Faster And With Greater Confidence.
CMC Pharma’s integrated model combines formulation, analytical, manufacturing, and regulatory expertise under one roof, enabling faster problem-solving and seamless data-to-decision flow.
The case studies below highlight how our scientific depth, flexibility, and regulatory insight have helped clients, from government agencies to small biotechs, overcome complex challenges in stability, solubility, and multi-API development. Each project demonstrates how we accelerate progress without compromising scientific rigor or regulatory compliance.
Explore the case studies below to see how we solve complex development challenges.
- Case Study #1: Developing a Long-Acting Injectable
- Case Study #2: Reformulation of an FDA-approved Drug
- Case Study #3: Responding to an FDA Deficiency Letter
- Case Study #4: Extending the Shelf-Life of an Oral Drug Product
- Case Study #5: Developing an Injectable Combination Formulation of Two APIs
- Case Study #6: Reformulation of a Hard-to-Solubilize Drug
Case Study #1: Developing a Long-Acting Injectable Formulation
Accelerating Innovation in Animal Health
Client Type: Virtual Start-up
Industry: Animal Health
Program Duration: Multi-year
Goal: Develop a long-acting injectable drug product to reduce dosing frequency and improve compliance in companion animals.
The Challenge
A virtual animal health start-up had a bold vision: create a long-acting injectable therapy that would replace multiple daily or weekly doses with a single, sustained treatment. But, they lacked the in-house CMC infrastructure–no laboratories, and no analytical, formulation or process development equipment—to turn that concept into a viable product. They needed a partner to quickly advance their product by identifying and preparing formulation prototypes for further development
Our Role
CMC Pharma became the client’s full development partner, integrating formulation, analytical, and manufacturing expertise from day one. Over multiple multi-year programs, we:
- Designed and evaluated multiple long-acting formulation prototypes against the target product profile
- Developed and validated analytical methods that were stability-indicating
- Optimized and prepared formulations for pharmacokinetic and pharmacology studies
- Scaled up manufacturing processes and validated a sterilization method
- Coordinated subcontractors for specialized testing (sterilization, particle size, dissolution/release, etc.)
- Generated ICH- and FDA-compliant data packages for regulatory use
- Developed a comprehensive tech transfer package and provided support for a transition to a client-selected CMO
- Collaborated with the client on patent filings on the lead formulations
What This Demonstrates
CMC Pharma’s integrated CMC model provides early-stage companies with the infrastructure, expertise, and regulatory insight they need to advance complex formulations quickly and cost-effectively.
By eliminating vendor handoffs and aligning development with regulatory strategy from the start, CMC Pharma helps innovative drug development companies reach critical milestones faster.
Case Study #2: Reformulation of an FDA-approved Drug
Rapid Development of a Concentrated Injectable for a Proprietary Delivery Device
Client Type: Mid-Sized Medical Device Company
Industry: Drug-Device Combination Products Program Duration: Multi-year
Goal: Reformulate an FDA-approved injectable drug into a concentrated, device-compatible version.
The Challenge
A medical device company needed to reformulate an existing injectable drug into a higher concentration suitable for their proprietary device, without compromising stability or therapeutic equivalence.
While the client had identified a target product profile, they lacked formulation and analytical development capabilities to prove compatibility, demonstrate long-term stability, and prepare for scale-up.
Our Role
CMC Pharma acted as the client’s full CMC development partner, providing end-to-end scientific, analytical, and process development support to:
- Develop and screen a series of concentrated formulation prototypes
- Establish and validate stability-indicating analytical methods
- Conduct ICH stability and device compatibility studies
- Optimize manufacturing parameters for scalability and compliance
- Prepare comprehensive CMC and tech transfer documentation
- Manage seamless transition to a client-selected CMO for GMP production
What This Demonstrates
CMC Pharma’s integrated formulation, analytical, and manufacturing expertise accelerates complex reformulation projects. Our collaborative approach allows clients to advance combination products quickly and confidently toward regulatory submission and market readiness.
Case Study #3: Responding to an FDA Deficiency Letter
Stabilizing a Drug-Device Combination Product and Achieving FDA Approval
Client Type: Global Medical Device Company
Industry: Combination Drug-Device Product
Program Duration: Multi-year
Goal: Resolve FDA concerns regarding analytical methods and demonstrate product stability to achieve IDE approval.
The Challenge
A global device manufacturer received an FDA deficiency letter questioning whether their analytical methods were stability-indicating. The agency requested additional data before allowing continued enrollment in their Investigational Device Exemption (IDE) study, putting their clinical and acquisition timelines at risk.
Our Role
CMC Pharma was engaged to lead a multi-year rescue program that included:
- Redesigning and optimizing analytical methods to meet FDA expectations
- Conducting forced degradation studies to establish stability-indicating capability
- Generating and interpreting high-quality cGMP analytical and stability data
- Preparing detailed, regulatory-sound technical reports aligned with FDA language
- Supporting the client’s direct interactions with the FDA
- Preparing drug product prototypes for use in an in vivo toxicity study
What This Demonstrates
CMC Pharma’s combination of scientific precision and regulatory insight enables clients to overcome high-stakes FDA challenges. Our integrated model produces defendable data packages that stand up to agency scrutiny, fast.
Case Study #4: Extending the Shelf-Life of an Oral Drug Product
Strengthening Military Readiness and Reducing Costs Through Stability Expertise
Client Type: U.S. Government
Industry: Medical Countermeasures
Program Duration: Multi-year
Goal: Extend the operational shelf-life of a critical drug product to reduce cost and improve logistics for active-duty service members.
The Challenge
The U.S. Government faced logistical and cost challenges due to a key drug products ’s short 3-month operational shelf-life. Each expiration cycle required replacement and reissuance of stockpiles worldwide. To extend the shelf-life and support FDA submission, the agency needed rigorous, cGMP-compliant stability data from validated analytical methods.
Our Role
CMC Pharma partnered with the government client to:
- Develop and validate analytical methods suitable for long-term stability monitoring
- Design and execute a cGMP stability study
- Generate and interpret data to support FDA filing extending the shelf life
- Draft regulatory-quality reports and assist in FDA communications
What This Demonstrates
CMC Pharma’s expertise in stability study design, analytical method validation, and regulatory communication helps clients, both commercial and government, extend product life cycles, save costs, and maintain readiness.
Case Study #5: Developing an Injectable Combination Formulation of Two APIs
Advancing Therapy Through Formulation Innovation
Client Type: U.S. Government
Industry: Medical Countermeasures
Program Duration: Multi-year
Goal: Develop and stabilize a dual-API injectable formulation
The Challenge
The U.S. Government sought to improve the standard of care by combining two active pharmaceutical ingredients (APIs) into a single formulation.
However, the project faced a critical technical obstacle: both APIs could be very unstable in solution formulations—threatening the product’s shelf-life and regulatory viability. Developing a stable, dual-API formulation required advanced analytical method development, stability testing, and formulation expertise under one roof.
Our Role
CMC Pharma partnered with the client on a multi-year development program to:
- Develop and validate stability-indicating analytical methods for both APIs
- Design and execute a cGMP-compliant stability study
- Formulate and produce non-GMP prototypes for feasibility and in vivo testing
- Improve solution stability for one API using novel formulation and stabilizing strategies
- Manage and interpret animal studies in rodents and non-human primates
- Generate regulatory-sound reports and technical data packages for continued development
What This Demonstrates
CMC Pharma’s expertise in stabilizing complex and unstable compounds enables government and commercial clients alike to transform challenging dual-API concepts into stable, scalable, and IP-protected products. Our integrated analytical, formulation, and regulatory model ensures faster progress toward FDA submissions.
Case Study #6: Reformulation of a Hard-to-Solubilize Drug
Overcoming Solubility Barriers for a Promising Therapeutic
Client Type: Small Biotech
Industry: Injectable Drug Products
Program Duration: Multi-year
Goal: Reformulate an existing drug product to improve solubility, stability, and performance using pharmaceutically acceptable excipients.
The Challenge
A small biotech company had developed a promising therapeutic, but its commercial potential was limited by poor solubility and stability in solution. The existing formulation restricted dosing flexibility and shelf-life, preventing advancement toward clinical evaluation.
The client needed a scalable reformulation that could meet target concentration and quality specifications using FDA-approved excipients for injectables without compromising safety or therapeutic integrity.
Our Role
CMC Pharma partnered with the client to rapidly identify, develop, and evaluate improved formulations through:
- Comprehensive solubility screening of pharmaceutically acceptable excipients to identify strategies for enhanced API solubilization.
- Creation and validation of methods to characterize solubility, stability, and potency.
- Iterative development of prototype formulations meeting target concentration and compatibility requirements.
- Generation of cGMP-aligned stability data to demonstrate viability for future IND-enabling work.
What This Demonstrates
CMC Pharma’s scientific depth in formulation and solubility enhancement helps small biotechs overcome critical barriers to clinical advancement. By combining analytical development, formulation optimization, and regulatory foresight, we transform complex solubility challenges into commercially viable drug products both quickly and efficiently.
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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.
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