Regulatory Classifications
Regulatory-Ready Development and Manufacturing Across Rx and OTC Products
Regulatory classification fundamentally shapes how drug products are developed, tested, manufactured, packaged, and supplied. Prescription innovator products, Rx generics, and OTC medicines each operate under distinct regulatory frameworks, bringing different expectations for analytical rigor, bioequivalence, labeling, serialization, and lifecycle management.
CPL supports all three regulatory classifications for semi-solid and non-sterile liquid drug products. By aligning formulation, analytical development, skin testing, manufacturing, packaging, and supply-chain execution to the regulatory pathway from the outset, CPL helps sponsors navigate complexity, accelerate approvals, and maintain reliable, compliant supply throughout the product lifecycle.
Rx Innovator
CPL supports prescription creams, gels, ointments, lotions, solutions, suspensions, and sprays from early formulation through IND-enabling studies, pivotal registration batches, and commercial GMP manufacturing.
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Rx Generics
For generic semi-solid and non-sterile liquid products, CPL integrates reverse engineering, formulation development, analytical method validation, bioequivalence strategy, and GMP manufacturing to support efficient approvals and competitive launches.
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OTC
CPL applies the same rigorous GMP, analytical, and microbiological controls to OTC products as we do to Rx programs, while adding specialized expertise in packaging, labeling, tamper resistance, and agile supply.
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Industry Challenge
Regulatory Pathways Increase Complexity Across the Lifecycle
CPL’s Solution
Classification-Specific Expertise, Delivered Through One Integrated Model
CPL combines regulatory insight with technical execution, ensuring that formulation design, analytical methods, process development, packaging, and supply chain planning are aligned with the product’s classification from the beginning. Across all regulatory classes, clients benefit from:
- Integrated analytical method development and validation
- Product testing, stability, and IVRT/IVPT skin testing
- Phase-appropriate manufacturability and scale-up planning
- Seamless tech transfer into GMP manufacturing
- Integrated packaging, labeling, serialization, and aggregation
- Strong change control and lifecycle management
Why Clients Choose CPL Across Regulatory Classifications
Regulatory Alignment Without Silos
CMC strategy, analytical methods, manufacturing, and packaging are developed together, not handed off.
Depth Across Rx and OTC
CPL understands the nuances that differentiate NDA, ANDA, and OTC pathways, and how to execute each efficiently.
Built for Inspection and Supply Continuity
Processes, documentation, and facilities are designed to withstand regulatory scrutiny and support long-term commercial supply.
One Partner from Molecule to Market
CPL supports programs at any stage, stepping in where needed or serving as an end-to-end CDMO.
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.
