Early-Phase Semi-Solid & Liquid Drug Product Development
Building a Robust Foundation for Topical & Non-Sterile Liquid Success
To start programs on the right foot, CPL’s early-phase development efforts combine pre-formulation, characterization, target product profile establishment, and rapid formulation screening with phase-appropriate analytical methods and in vitro skin testing. By integrating manufacturability, stability, and regulatory expectations from day one, we help innovators de-risk programs, select the right lead formulations, and move quickly and confidently toward IND and first-in-human clinical studies on schedule.
Integrated Early-Phase Development for Semi-Solids & Liquids
From the earliest stages of our programs, CPL unites formulation, process, analytical, and product testing expertise to de-risk development, enable IND-ready data packages, and design scalable processes.
Early-Phase Product & Formulation Development
From early API solubility and excipient compatibility work through prototype batches, stability screening, and Design of Experiments, CPL designs robust, manufacturable formulations for even the most challenging semi-solids and non-sterile liquids. Our integrated teams unite formulation, analytical, and manufacturing expertise to select the right lead candidates and design processes that scale smoothly. By thinking ahead to GMP manufacturing from day one, we accelerate development, de-risk key milestones, and set products up to perform reliably in the lab, plant, and marketplace.
Discover Product & Formulation Development Capabilities
Manufacturability & Process Development
CPL’s teams have manufacturability at the forefront from day one. For semi-solids and non-sterile liquids, our process development teams anticipate hurdles like microbiological control, formulation complexity, long-term stability, and scale-up risks, and design processes accordingly before timelines are threatened. We map CPPs (Critical Process Parameters) to CQAs (Critical Quality Attributes), translating processes from lab-scale to larger runs, aligning documentation and controls with cGMP expectations.
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Analytical Method Development
CPL treats analytical development as a core design element of early-phase programs, not merely a task to be checked off the list. We create phase-appropriate methods that are accurate and reproducible, while anticipating future needs for process validation, later-phase clinical runs, and commercial cGMP manufacturing. By working in lockstep with the formulation team, we shorten development cycles, minimize method rework, and ensure your analytical methods truly reflect how the product will be made, tested, and released at scale.
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Product Testing in Early-Phase Development
CPL’s quality control and analytical labs provide the full spectrum of release, stability, and performance testing needed to advance early-phase programs. Our cross-functional team of analytical chemists, microbiologists, and process engineers supports early-phase clinical batch manufacturing. From method execution to data interpretation, every result is generated under cGMP and aligned with global regulatory expectations, building strong, phase-appropriate data packages for your next milestone.
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Clinical Manufacturing
CPL’s toxicology batch and clinical manufacturing services provide a reliable supply of semi-solid and non-sterile liquid drug products for early development through late-phase clinical trials. Drawing on 35 years of experience with topical and liquid drug products, we produce early-phase batches with the precision, consistency, and regulatory rigor your program demands. Batch sizes from 20kg to 5,000kg support everything from first-in-human studies to later-stage trials.
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Non-Sterile Liquid Suspension Dose Uniformity
Dedicated to Excellence
from Molecule to Commercialization
CPL supports programs from early-phase through commercial launch, combining preformulation insight, robust semi-solid and non-sterile liquid development, scalable process design, and clinical and commercial manufacturing.
Pharmaceutical Development Services
Pharmaceutical Development Services
Comprehensive expertise that turns molecules into scalable, compliant, market‑ready semi-solid and non-sterile therapies.
Analytical & Product Testing
Analytical & Product Testing
Robust analytics power confident development and manufacture of topical and non-sterile liquid products.
Clinical & Commercial Manufacturing
Clinical & Commercial Manufacturing
More than three decades of GMP manufacturing experience from clinical supply through commercialization.
Packaging, Labeling & Serialization
Packaging, Labeling & Serialization
Integrated packaging, serialization, and aggregation ensure compliant, continuous commercial supply.
Semi-Solid & Non-Sterile Liquid Expertise
Semi-Solid & Non-Sterile Liquid Expertise
Pure-play CDMO for semi-solids and non-sterile liquids, with advanced micro encapsulation capabilities.
Unique Product Handling Experience
Unique Product Handling Experience
Infrastructure and expertise to manage complex, higher-risk semi-solid and non-sterile liquid products.
FAQs
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CPL is a specialist pharma CDMO focused on semi-solids and non-sterile liquids. Our product development team of 35 scientists and technical experts supports early-phase product and formulation development for creams, ointments, gels, lotions, solutions, and suspensions. Services include pre-formulation and product characterization, formulation development, manufacturability studies, early process development, analytical method development, IVPT/IVRT-based testing, and clinical batch manufacturing. This integrated approach helps de-risk IND-enabling work and prepares drug products for later-stage GMP manufacturing and process validation in the pharmaceutical industry.
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Unlike pure development houses, CPL designs semi-solid and liquid formulations from the start, with scale-up and tech transfer in mind. Our teams map CPPs to CQAs, perform manufacturability studies on emulsions, gels, ointments, solutions, and suspensions, and evaluate equipment fit for non-sterile liquid manufacturing and semi-solid dosage form manufacturing. By understanding process parameters early, we simplify scale-up and support a smoother path to commercial manufacturing.
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CPL’s analytical development services focus on building phase-appropriate methods that will grow with your program. We provide analytical method development and analytical method validation (ICH Q2) for assay, related substances, content uniformity, viscosity, pH, particle size, and more. This foundation streamlines CMC packages for INDs and prepares data sets that will ultimately support NDA, ANDA, or 505(b)(2) submissions.
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As a CDMO with extensive experience serving Canada, US, and global markets, CPL provides GMP clinical batch manufacturing for semi-solids and non-sterile liquids, including topical products, nasal sprays, oral suspensions, and other liquid pharmaceuticals. We support clinical trial manufacturing, registration batch manufacturing, and phase-appropriate process validation. Integrated supply chain management, container closure system expertise, and robust quality control testing help ensure reliable clinical supply while laying the groundwork for later commercial scale-up.
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.
