Rx Innovator Semi-Solid & Liquid Drug Products
Regulatory-Ready Development & GMP Manufacturing for Rx Products
As a pure-play CDMO for semi-solid and non-sterile liquid drug products, CPL helps Rx innovators turn development strategies into inspection-ready realities. We support prescription creams, gels, ointments, lotions, solutions, suspensions, and sprays from early formulation through IND-enabling studies, pivotal registration batches, and commercial GMP manufacturing. Integrated analytical development, skin and product testing, packaging, and serialization are aligned with global regulatory expectations, enabling strong submissions and a reliable commercial supply of compliant, high-quality drug product.
Regulatory, Quality & CMC Support for Rx Semi-Solid and Liquid Products
For prescription innovators, CPL connects formulation, analytics, manufacturing, and packaging with the regulatory end in mind, building supporting documentation for CMC packages, analytical methods, and product testing strategies that withstand agency scrutiny and support efficient drug product approvals.
Analytical Method Development Expertise Enables Smooth Regulatory Filings
CPL approaches analytical method development as a strategic enabler for Rx semi-solid and non-sterile liquid products, not just a compliance checkbox. Our scientists design phase-appropriate methods to handle complex formulations for creams, ointments, gels, lotions, solutions, suspensions, and sprays, addressing challenges such as particle size control, content uniformity, and impurity profiling. Using ICH Q2-aligned principles, we build robustness from the start, then refine through method optimization and ultimately validation. The result is fit-for-purpose methods that reliably support release, stability, tech transfer, and ultimately successful regulatory submissions.
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Product Testing Expertise Ensures Compliance
Product testing services conducted by CPL’s highly experienced team are built to meet the rigorous requirements for Rx semi-solid and non-sterile liquid drug products. We test critical quality attributes to inform process development, ongoing process control, and the high-quality drug product. Stability studies comply with ICH requirements and support shelf-life assignments, comparability, and post-approval changes. All data are generated under cGMP, supporting robust CMC packages for regulatory filings.
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Rx Innovator Regulatory Submission Support
Our team supports NDA submissions with integrated CMC expertise for semi-solid and non-sterile liquid drug products. Our teams align formulation, process development, analytical method validation, and product testing with current Health Canada, FDA, and EU requirements, as well as the expectations of other leading global regulators, generating robust data packages that withstand regulatory scrutiny. Analytical and product testing programs are designed with submission endpoints in mind, helping to demonstrate commercial readiness. The result is stronger dossiers, smoother agency interactions, and a more confident path to approval.
Packaging, Labeling, Serialization & Aggregation
CPL’s primary and secondary packaging for semi-solids and non-sterile liquids is fully integrated with our clinical and commercial manufacturing, combining precision filling with flexible formats for tubes, bottles, and foil sachets. Fully integrated tube and bottle lines, plus two portable serialization systems, enable coding, verification, and aggregation at the carton, bundle, case, and pallet levels across all packaging lines. We meet US DQSA and DSCSA (Drug Supply Chain Security Act) expectations, as well as EU FMD requirements, using GS1-aligned standards and proven platforms such as TraceLink, Optel, and Loftware.
Explore Packaging, Labeling & Serialization CapabilitiesCPL Experience Spotlight
CPL Addressed Product Stability Challenges
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 focuses exclusively on semi-solid and non-sterile liquid prescription products, including creams, ointments, gels, lotions, solutions, suspensions, nasal sprays, and topical sprays. We support programs from early product and formulation development through clinical and commercial GMP manufacturing, packaging, and serialization, providing a single, integrated partner for Rx innovators.
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Our teams align formulation, process development, analytical method validation, and product testing with current expectations from the FDA, Health Canada, EMA, and other global regulators. We design CMC strategies and data packages around NDA requirements, generate submission-ready reports, and support responses to agency questions. The result is stronger dossiers, smoother regulatory interactions, and a more confident path to approval.
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CPL treats analytical method development as a strategic enabler, not a checkbox. We build ICH Q2-aligned methods that can handle complex semi-solid and liquid matrices, then validate them for release, stability, and process validation. Product testing programs characterize critical quality attributes and support comparability, scale-up, and post-approval changes. Together, these capabilities underpin robust CMC packages and reliable, inspection-ready data.
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From the outset, we design formulations and processes with commercial manufacture in mind. Our teams conduct scale-up studies, tech transfer, and process validation, then integrate primary/secondary packaging, serialization, and aggregation under cGMP. Coupled with resilient supply chain management and strong OTIF performance, this ensures that once your prescription drug product is approved, CPL can reliably support launch and long-term commercial supply.
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.
