Development Phase
Phase-Appropriate Development for Semi-Solid & Non-Sterile Liquid Drug Products
Drug product development is not a single step; it is a progression. As programs move from early feasibility through late-phase readiness and into commercialization, expectations for robustness, documentation, scalability, and compliance increase dramatically.
CPL supports semi-solid and non-sterile liquid drug products across all development phases, applying the appropriate level of scientific rigor, analytical depth, and manufacturing discipline at each stage. By aligning formulation, process, analytical, and manufacturing teams from the outset, CPL helps sponsors reduce risk, avoid rework, and move confidently from molecule to market.
Early-Phase Development
Formulation screening, phase-appropriate analytical methods, IVRT/IVPT insights, and early manufacturability assessments are integrated to support IND-enabling studies and first-in-human trials.
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Late-Phase Development
Formulation robustness, analytical method validation, process characterization, stability programs, and preparation of registration-ready CMC data packages.
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Commercialization & Commercial Supply
Validated processes, integrated packaging and serialization, and disciplined supply-chain execution, ensuring inspection readiness, reliable product availability, and long-term lifecycle success
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Industry Challenge
Misaligned Development Creates Downstream Risk
CPL’s Solution
Development Designed for the Full Product Lifecycle
CPL’s development model ensures that every phase builds deliberately on the last. Rather than resetting at each milestone, formulation, analytical methods, process parameters, and documentation evolve continuously, creating momentum instead of friction.
- Integrated formulation, analytical, and process development
- IVRT / IVPT skin testing embedded early
- Early manufacturability and scale-up planning
- Seamless tech transfer into GMP manufacturing
- Clinical and commercial production under one roof
Why Clients Choose CPL Across Development Phases
Phase-Appropriate Expertise
CPL applies the right level of rigor at the right time, avoiding early-phase over-engineering and insufficient late-phase preparation.
Continuity Without Handoffs
Knowledge, data, and accountability remain within one organization from early development through commercialization, reducing regulatory, quality, technical, time, and cost risks.
Integrated Analytics & Skin Testing
Analytical method development, product testing, and IVRT/IVPT directly inform development decisions, saving time and money.
Commercial Mindset from Day One
Development is guided by manufacturability, validation, and long-term supply realities.
Commitment.
Partnership. Legacy.
Leverage CPL’s 35 years of expertise in non-sterile liquids and semi-solids to ensure your program's success. We’ll support your product from molecule to market, or step in at any stage of its product lifecycle.
