Packaging & Labeling

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Clinical Supply Delivered with Precision, Compliance, and Reliability

Corealis Pharma provides clinical packaging and labeling services designed to support the efficient delivery of oral solid drug products to clinical trial sites worldwide. Our integrated approach ensures that drug products are packaged, labeled, and distributed in compliance with regulatory requirements while maintaining flexibility for evolving clinical protocols.

From early-phase studies to more complex trial designs, we deliver clinical supplies with precision, reliability, and speed.

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Preparing Clinical Materials for Trial Readiness

Clinical packaging and labeling are critical steps in ensuring that drug products are delivered safely, accurately, and compliantly to patients and trial sites. At Corealis, we manage the packaging, labeling, storage, and distribution of clinical trial materials within a controlled GMP environment.

Our teams ensure that each batch is packaged according to protocol requirements, including blinding, labeling, and patient-specific configurations, while maintaining full traceability and quality oversight.

Our Clinical Packaging Workflow

  1. Packaging Design & Planning

    We define packaging configurations based on study protocols, dosing requirements, and regulatory guidelines.


  2. Clinical Packaging Execution

    Drug products are packaged using appropriate formats such as bottles, blisters, or pouches, including blinded or double-blinded designs when required.


  3. Labeling & Compliance

    Labels are developed and applied in accordance with clinical and regulatory requirements, ensuring accuracy and traceability.


  4. Distribution & Logistics

    Packaged materials are stored, managed, and distributed globally with reliable logistics coordination and regulatory compliance.

Technical Capabilities

Packaging Formats

  • Blister packaging 

  • Bottling 

  • Pouching 

  • Patient kit preparation 

Clinical Trial Packaging

  • Blind and double-blind study packaging 

  • Placebo matching and comparator packaging 

  • Clinical batch packaging for Phase I, II, and early Phase III studies 

Labeling Services

  • Clinical label generation and application 

  • Multi-language labeling support 

  • Protocol-specific labeling configurations 

  • Regulatory-compliant labeling processes 

Storage & Distribution

  • Clinical supplies warehousing and inventory management 

  • Global distribution across North America, Europe, UK, and Australia 

  • Coordination with customs brokers for smooth cross-border shipments 

  • Regulatory-compliant logistics management 

These capabilities ensure clinical materials are delivered accurately, efficiently, and in compliance with global regulatory requirements.

Typical Timeline

From Molecule to Clinical Supply

A structured development pathway designed to accelerate oral solid dose programs from early formulation to GMP clinical manufacturing. While timelines vary depending on API complexity and formulation strategy, a typical development pathway may include:


  • Pre-Formulation & Method Evaluation:

    • 1-2 weeks

  • Prototype Development 5-8 Prototypes:

    • 4-5 weeks

  • Engineering Batch:

    • 2-3 weeks

  • GMP Batch Preparation & Planning:

    • 2 weeks

  • GMP Manufacturing, Release and QA Review:

    • 6 weeks

  • Report:

    • 4-6 weeks

Typical duration:
4–6 months or less.

*Timelines may vary depending on program complexity and development strategy.

Key Packaging & Labeling Equipment

Corealis utilizes specialized equipment to support clinical packaging and labeling operations. 

Representative equipment includes:

  • Blister packaging lines 

  • Bottle filling and sealing systems 

  • Pouching systems 

  • Label printing and application systems 

  • Clinical kit assembly stations 

  • Packaging inspection and verification systems 

These systems ensure accurate, efficient, and compliant packaging of clinical trial materials.

See Our Development Facilities

Corealis operates more than 60,000 square feet of integrated formulation, analytical, and GMP manufacturing facilities located in Laval, Canada.

Visiting our laboratories provides an opportunity to meet the scientists supporting your program and see firsthand how our teams collaborate to solve complex formulation challenges.

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FAQ

What types of packaging formats does Corealis support?

Can Corealis support blinded clinical studies?

Do you provide labeling services?

Can Corealis support global distribution?

How do you ensure packaging accuracy?

How long does clinical packaging take?

Learn more how Corealis can support your drug product development needs.

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