Global fill & finish solutions and clinical packaging expertise

Global fill & finish solutions and clinical packaging expertise

Navigate through our specialized services for aseptic fill & finish, clinical packaging, and supply chain logistics.

We guide a diverse portfolio of worldwide customers through the sterile fill & finish process and packaging and labeling of injectable drug products, adhering to GMP standards. With our state-of-the-art aseptic fill & finish facility and partnerships with qualified contract facilities, we ensure the highest quality and compliance.

Our team customizes and optimizes packaging, labeling and supply strategies to meet your stringent timelines and study design requirements.

Precision sterile fill & finish manufacturing services

Precision sterile fill & finish manufacturing services

Within our GMP-compliant facility, we specialize in sterile fill & finish services, ensuring the precise aseptic preparation of liquid drug formulations in vials. Our capabilities encompass a diverse range of pharmaceutical products, including nanomedicines and small-molecules, with batch sizes tailored for clinical trial material.

Our aseptic production area spans 300 m² and is meticulously designed following EU GMP Annex 1 standards. It features Grade C cleanroom areas with specialized facilities, such as closed isolator filling rooms equipped with automated VHP decontamination cycles.

Additionally, we provide dedicated spaces for weighing, compounding, filling and visual inspection, all supported by state-of-the-art environmental control and monitoring systems.

Streamlined clinical packaging and logistics solutions

Ardena offers comprehensive clinical logistics services, ensuring the reliable delivery of GMP-compliant materials to trial sites. Focused on flexibility, agility and reliability, we tailor packaging, labeling and supply strategies to meet stringent timelines and study designs, supporting effective clinical trials.

Our packaging services encompass primary and secondary packaging, kit assembly and labeling, all tailored to fit specific trial protocols. From the primary packaging of drug products to patient kit assembly and labeling, we utilize tamper-proof materials and customizable solutions to meet clinical protocol requirements.

Additionally, our logistics expertise spans all phases of early clinical development, offering temperature-controlled storage, IATA packing compliance, randomization services and comprehensive support for comparator sourcing and distribution.

With a commitment to seamless integration and reliable execution, Ardena’s clinical trial supply and logistics services optimize trial efficiency while ensuring compliance and patient safety.

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