Formulation Development & Analytical Method Development

Formulation Development Capabilities

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

• Dosage forms mastered: Immediate- and modified-release tablets (including matrix, delayed, sustained-release), oral disintegrating tablets, coated pellets, particle coating for capsule fill, semi-solid creams, and gel.
• Methodologies employed: Design of Experiments (DOE) within a Quality-by-Design (QbD) approach for formulation development, 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.

Analytical Method Development Services

UPM delivers comprehensive analytical method development services to assure quality, compliance, and regulatory readiness:

• 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.

Industries & Applications Served

UPM provides 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. 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 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. 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

Choosing the right CDMO for your formulation development and analytical 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 formulation development to analytical testing, 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 smaller CDMO with big pharma-quality systems.
• Controlled substance & high-potent handling: DEA-approved vaults and vault-backed labs within a secure, cGMP-compliant environment.

Tell Us More About Your Project – Request a Quote Today

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