Clinical & Registration
Batch Manufacturing
Phase-Appropriate Clinical Supply, Built for Commercial Success
Semi-solid and non-sterile liquid clinical and registration batches demand commercial-grade quality with far greater flexibility. Batch sizes must adapt to evolving clinical needs, and formulations or processes may need refinement as new data emerges. From the first lab batch onward, CPL designs with the end in mind, building processes that can scale reliably to commercial volumes while preserving the agility required in early development. The result is robust, phase-appropriate supply and seamless scale-up.
Clinical Manufacturing of Semi-Solid and Liquid Drug Products
- Phase I, II & III Trials
- 20kg to 5,000kg Batch Sizes
- Flexible Operations
- Scalability
CPL’s clinical manufacturing services provide a reliable, GMP-compliant supply of semi-solid and non-sterile liquid drug products for Phase I, II, and III trials. With 35 years of experience formulating and manufacturing topical, nasal, and oral liquid formulations, we produce investigational products with the precision, consistency, regulatory rigor, and dependable supply your clinical program demands.
Batch sizes range from 20kg to 5,000kg, supporting early- and later-phase clinical supply runs. Every batch is manufactured, tested, and packaged in a phase-appropriate manner. Our quality- and regulatory-focused approach, combined with proven experience in complex semi-solid and non-sterile liquid dosage forms, gives sponsors the confidence that each batch supports both today’s trial needs and tomorrow’s approvals.
Registration Batches that Streamline Approval and Prove Commercial Readiness
- Quality Data Generation
- Approval Support
- Accelerate Commercialization
- Risk Reduction
Registration batch manufacturing requires proving your process is ready for regulatory approval and commercial scale. Our teams work hand in hand with your formulation, analytical, quality, and regulatory agencies to anticipate CMC risks, tighten controls, and generate the data regulators require.
For semi-solid and non-sterile liquid products, we design and execute registration batches at commercial scale, while retaining the flexibility to adjust batches as new insights emerge. We streamline documentation to support INDs, IMPDs, NDAs, and post-approval filings, and ensure seamless scale-up and tech transfer. The result is on-time, audit-ready registration batches that demonstrate robust, reproducible performance and accelerate your path to market.
Specialized Capabilities & Expertise for Demanding Products
CPL reliably develops and manufactures demanding semi-solid and non-sterile liquid products, including male and female hormone therapies, corticosteroids, alcohol-containing formulations, and light-sensitive products, applying rigorous controls to protect potency, stability, and operator safety. We also have refrigerated storage areas for handling APIs that require 2-8°C conditions prior to manufacturing.
CPL Experience Spotlight
Clinical Batch Process Adjustment Needed for Topical Gel
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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Clinical batch manufacturing (or clinical trial manufacturing) produces product supply for use in Phase I–III studies under cGMP, with flexible batch sizes and required documentation. Registration batch manufacturing typically focuses on 1/10 of the commercial-scale batches, demonstrating robust, reproducible processes in support of NDA, ANDA, or MAA submissions. In some instances, the Phase III clinical batches can also be submitted as registration batches to expedite approval timelines and save costs.
CPL supports both clinical batch manufacturing and registration batch manufacturing for semi-solid and non-sterile liquid products, aligning development, clinical, registration, and commercial manufacturing needs from day one.
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CPL operates as a pharmaceutical CDMO under FDA, Health Canada, and EU-aligned cGMP regulations for investigational and commercial drug products. We have in place a robust Quality Management System that ensures all aspects of manufacturing, from development through to registration, comply with cGMP regulatory standards.
Analytical method validation, USP/EP/JP testing, stability testing services, and container-closure system qualification help ensure each clinical and registration batch consistently meets CQAs (critical quality attributes) such as potency, content uniformity, rheology, and microbiological quality, supporting reliable clinical and commercial manufacturing for the pharma industry.
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In clinical manufacturing, agility and flexibility are essential to accommodate evolving protocols, shifting timelines, and the need for rapid iteration based on clinical trial data. Small-batch production must align with formulation refinements and changing required product volumes, often on compressed timelines. Flexible manufacturing processes, supported by robust project management, adaptable equipment, and cross-functional teams, enable the timely delivery of clinical supplies, reduce costly delays, and ensure the product’s integrity and consistency from batch to batch.
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When choosing a CDMO for clinical trial manufacturing services and registration batch manufacturing, sponsors should prioritize:
- Proven cGMP and regulatory track record
- Deep expertise in semi-solid and non-sterile liquid topical
- Strong technology transfer and scale-up capabilities
- Integrated analytical development, product testing, and skin testing services (including IVRT / IVPT for topical products)
- Robust supply chain management, storage capacity, and transparent communication
Industry guidance stresses risk mitigation, scalability, and robust quality systems as key CDMO selection criteria for clinical and commercial GMP manufacturing.
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.
