Pharmaceutical Formulation Development Services

Exceptional pharmaceutical formulation development grounded in scientific precision powers market-ready drug solutions at UPM Pharmaceuticals. With over 25 years of industry experience and a family-owned legacy, our Bristol, Tennessee, facility spans 475,000 sq ft of cGMP-compliant manufacturing space with dedicated DEA vaults and 34,500 sq ft of advanced analytical laboratories. From preformulation through commercial scale, our contract pharmaceutical formulation development services are built to advance oral solid and semi-solid drug products with the scientific rigor and regulatory precision your program demands.

Formulation Development Capabilities

UPM's contract pharmaceutical formulation development services advance oral solid and semi-solid compounds from preformulation concept through clinical and commercial scale-up:

  • Preformulation studies: Physicochemical characterization, solubility screening, excipient compatibility, polymorphism evaluation, hygroscopicity, and stability profiling to establish a solid scientific foundation before formulation design begins.
  • Dosage forms mastered: Immediate- and modified-release tablets (including matrix, delayed, extended, sustained-release), oral disintegrating tablets, coated pellets, particle coating for capsule fill, semi-solid creams, and gel.
  • Methodologies employed: Quality-by-Design (QbD) formulation development using Design of Experiments (DOE), with expedited content uniformity, dissolution profiling, compressibility, friability, particle size, powder flow, and tap density evaluations.
  • Scaled development: From 50 kg pilot batches (low-humidity suites available) to clinical IND/Phase I–III minibatches and commercial-scale manufacturing.
  • Specialized expertise: Oral peptide formulations, high-potent APIs, controlled substances (Schedules II–V), and hormone products developed using precise formulation development process controls.
  • Equipment readiness: Full in-house R&D and pilot suites, including granulators, tablet presses, fluid-bed processors, encapsulators, coating systems, and semisolid processors—all equipped to support seamless tech transfer and scale-up.

Our Pharmaceutical Formulation Development Process

UPM's pharmaceutical formulation development process carries your compound from early characterization through clinical and commercial readiness with consistent scientific oversight at each stage:

  1. Preformulation and Feasibility — Physicochemical profiling, excipient compatibility screening, and solubility and polymorphism evaluation define the formulation design space before prototype development begins.

  2. Formulation Design and Optimization — Prototype development using QbD and DOE methodologies generates dissolution profiles, content uniformity data, and accelerated stability results to identify the optimal formulation candidate.

  3. Analytical Method Development and Validation — Concurrent development and validation of HPLC/UPLC and supporting analytical methods provides reliable, GMP-ready data to guide formulation decisions, release testing, and ICH stability programs.

  4. Pilot-Scale Manufacturing and Scale-Up — Transition from laboratory-scale to pilot and clinical batch production, with full documentation to support IND filings and CMC submissions. Learn more about scale-up support for clinical trials.

  5. Technology Transfer and Commercial Readiness — Structured technology transfer to commercial manufacturing, including process validation, batch record generation, and regulatory filing support.

Analytical Method Development and Validation Services

UPM delivers comprehensive analytical method development and validation services to assure quality, compliance, and regulatory readiness throughout every stage of your formulation program:

  • Laboratory resources: A 34,500 sq ft cGMP lab with subdivisions for analytical development, raw materials, microbiology, drug product QC, and metrology.
  • Robust instrumentation: UPLC/HPLC (including dual-wavelength/PDA detectors), GC/headspace, ICP-MS with microwave digestion, dissolution baths, UV spectrophotometers, FT-IR, TOC analyzers, and laser particle analyzers.
  • Regulatory compliance: ICH Q3D/USP elemental impurity testing and risk assessments, method development, validation, qualification, and transfer, all GMP-compliant.
  • Analytical services: Stability testing, impurity profiling, purity assays, microbial testing, excipient compatibility, solubility, hygroscopicity, in-process testing, forced degradation, method robustness, specificity, precision, LOD/LOQ, linearity, and full ICH stability studies.

For a deeper look at how UPM approaches this discipline, read our overview of analytical method development and validation.

Industries & Applications Served

UPM provides contract pharmaceutical formulation development services for a wide range of therapeutic areas, from specialty generics to complex, niche drug products. Our expertise spans oral solids, semi-solids, high-potent compounds, peptides, and controlled substances, supporting both small molecule and select biologic drug delivery systems. Product types and application specializations include:

  • Modified-release and extended-release oral solid dosage forms, including matrix tablets, delayed-release capsules, and coated pellet systems

  • Semi-solid formulation development for creams, gels, and ointments requiring specialized containment and processing

  • High-potency API formulation development conducted under DEA-compliant, vaulted laboratory conditions

  • Oral peptide formulations, a specialty area in which UPM has advanced multiple compounds to commercialization

  • Specialty generics and complex niche products requiring advanced solubility, stability, or modified-release strategies

This flexibility allows us to meet the needs of emerging biotechs, established pharmaceutical companies, and government contracts requiring secure, cGMP-compliant production environments.

Regulatory Support & Compliance Expertise

Every drug product formulation we develop is guided by rigorous regulatory compliance. Our teams prepare chemistry, manufacturing, and controls (CMC) documentation in alignment with FDA, ICH, and DEA requirements, ensuring your submission packages meet global standards. We also offer full support for pre-approval inspections (PAIs), post-approval changes, and international regulatory filings. Our Quality and Regulatory Support team works directly alongside formulation and analytical scientists to maintain documentation standards from first batch through commercial release. This integration of formulation development process expertise with regulatory insight accelerates time-to-market and reduces the risk of costly delays.

Why Partner With UPM for Pharmaceutical Formulation Development

Choosing the right contract CDMO for your pharmaceutical formulation development and analytical method development needs can determine the success of your project. UPM combines proven scientific expertise with the flexibility and responsiveness required to deliver results on time and to the highest quality standards.

  • End-to-end integration: All stages—from preformulation and formulation development to analytical method development and validation, tech transfer, scale-up, manufacturing, and packaging—happen under one roof, minimizing risk and accelerating timelines.
  • National manufacturing presence: One of the few independent CDMOs with extensive late-stage commercial manufacturing pedigree, bringing over 80 compounds to market and producing billions of tablets and hundreds of millions of capsules annually.
  • Agile scientific team: Dedicated project teams, responsive turnaround, and personalized service reflective of a family-owned CDMO with enterprise pharma-quality systems.
  • Controlled substance & high-potent handling: DEA-approved vaults and vault-backed labs within a secure, cGMP-compliant environment.

Take a virtual tour of our formulation development and analytical laboratory facilities to see our capabilities firsthand.

What is pharmaceutical formulation development?
Pharmaceutical formulation development is the scientific process of designing, testing, and optimizing a drug product's composition, dosage form, and manufacturing process to achieve the desired efficacy, safety, and stability profile. At UPM, this work begins with preformulation studies and extends through analytical method development, pilot-scale manufacturing, and commercial technology transfer.
What is the difference between formulation development and analytical method development?
Formulation development focuses on designing and optimizing the drug product composition and manufacturing process. Analytical method development creates and validates the testing procedures used to measure the drug's identity, purity, potency, and stability. The two disciplines work in parallel throughout the development lifecycle, as reliable analytical methods are required to generate the data that guides every formulation decision.
Why outsource pharmaceutical formulation development to a contract CDMO?
Outsourcing pharmaceutical formulation development to a contract CDMO provides access to specialized expertise, cGMP-compliant facilities, and advanced instrumentation without the capital investment of building internal capabilities. A full-service CDMO also eliminates the coordination burden of managing multiple vendors across formulation, analytical testing, and manufacturing, reducing project risk and compressing timelines from IND through NDA.
Does UPM handle controlled substance and high-potent API formulation development?
Yes. UPM's Bristol, Tennessee, facility includes DEA-approved Schedule II–V vaults and vault-backed laboratories, enabling secure formulation development for controlled substances, high-potent APIs, and hormone products. Learn more about our high-potent API handling capabilities.

Ready to Outsource Your Pharmaceutical Formulation Development? Request a Quote!

Contact us and submit your project details to get started with our contract pharmaceutical formulation development and analytical method development services. A UPM Pharmaceuticals specialist will follow up promptly to discuss your project roadmap and provide a custom formulation development plan and pricing estimate.