Whether you are conducting small-scale Phase I studies, large-scale global Phase III studies, or commercial supply. We will fulfill your request with the expertise to overcome project challenges and deliver the highest quality, cost-effective solutions.
Our investments in advanced automated equipment and specialized handling suites enable us to achieve industry-leading efficiency, accuracy, capacity, and flexibility, expediting the progress of your product into the clinical and commercial settings
With strategically located facilities spanning in the USA we bring GMP primary, secondary, high and low volume packaging, as well as package engineering and patient kit design to your doorstep. We work closely with you to engineer solutions that optimize material efficiency and deliver exceptional results within critical trial and commercial timelines.
GMP Capabilities
We conduct GMP primary packaging at our end to end manufacturing facilities located in the United States allowing us to supply your studies virtually anywhere in the world. Through close collaboration with you, we develop solutions that not only optimize material usage but also align with your critical trial timelines.
Our Primary Packaging Services Encompass:
- Automated, high-speed blistering and bottling lines
- Semi-automated and hand-fill bottling lines for smaller batches
- Temperature and humidity controlled packaging suites to preserve product integrity
- Oxygen and light sensitive packaging options to safeguard stability and efficacy
- Package engineering and patient kit design service
Low-Volume Commercial Packaging
Securing timely commercial packaging services for low-volume drugs, including niche and orphan products, can be a daunting task. However, we possess the capacity, commercial serialization capabilities, flexibility, and extensive expertise in managing complex supply chains to support your commercial packaging needs effectively.
Secondary Packaging
Safeguard your valuable products. We accommodate single or multiple products, tailored to meet the specific requirements of your study. Receive manual patient kit assembly, as well as semi-automated and automated wallet sealing and high-speed automated carding, catering to studies of all sizes. When it comes to temperature-sensitive products and those with strict environmental requirements, your protection is ensured through our secondary packaging in refrigerated and frozen packaging rooms, or over dry ice, based on your project needs.
Our labeling system features a comprehensive multi-lingual label phrase library, and we offer versatile label design options for your studies. Choose from single panel labels, booklet labels, or our unique safe storage labels. Convenience is key, as single panel and safe storage labels can be conveniently reviewed and approved before being printed and meticulously inspected at our state-of-the-art facilities.
Capabilities
- Automated wallet sealing: Securely package your clinical materials with efficient automated wallet sealing processes.
- Hand assembly: Our skilled team ensures meticulous hand assembly, guaranteeing attention to detail and accuracy.
- Scan and assembly: Utilizing advanced scanning technology, we achieve precise assembly of clinical materials, maintaining consistency and integrity.
- Cold room packaging: Preserve the efficacy of temperature-sensitive products with secondary packaging in refrigerated and frozen rooms, adhering to stringent environmental controls.
- Patient kit design services: Enhance patient convenience and compliance through our dedicated team’s tailored patient kit design services.
- Label design and printing: Our expertise in label design and printing delivers visually appealing labels that comply with regulations and effectively convey essential information.
- Multiple label types (single/booklet): Accommodate diverse labeling needs with flexibility and versatility, including single panel and booklet labels.
- Harmonized labeling system: Streamline global regulatory compliance through our harmonized labeling system across different markets.
- Global phrase library: Facilitate accurate translations and consistent messaging across diverse regions with our extensive multi-lingual label phrase library.
Package Engineering & Patient Kit Design
Conquer complex clinical packaging challenges. Our team of specialists is dedicated to understanding your unique packaging requirements and creating solutions tailored to your needs.
Whether it’s cost-effectiveness, flexibility, or an enhanced patient experience, we optimize your packaging solution based on your priorities. Leverage cutting-edge tools and services, including immersive 3D renderings, exquisite carton prototypes with tailored foam inserts, and tangible 3D printed blister card samples that leave a lasting impression, bringing your vision to life.
- Strategic management of clinical supplies to optimize package configuration and give you a competitive edge
- User-friendly, and child-resistant packaging options that enhance safety and convenience
- Secondary packaging and patient kit designs
- Foam inserts engineered to minimize the risk of breakage during transit, ensuring your products arrive intact and pristine
- Carton prototypes providing a visual representation of the final packaging design that leaves a lasting impression on customers
- 3D renderings and physical samples that effortlessly convey the essence of your packaging concept, allowing your vision to shine through with clarity and impact
- Primary packaging designs to suit even the most demanding blistering requirements
Related Services
FAQs
Here are some frequently asked questions about Packaging
We offer a comprehensive range of packaging services for drug products, including blister packaging, bottle filling for tablets and capsules, sachet and stick pack filling for powders, and secondary packaging services such as cartoning and serialization. Our services are designed to meet the specific needs of our clients, ensuring product integrity, patient safety, and regulatory compliance.
Ensuring packaging compliance with regulatory standards involves adhering to current Good Manufacturing Practices (cGMP), using materials that meet regulatory requirements, and implementing quality control processes throughout the packaging line. Our regulatory affairs team stays updated on global packaging regulations and guidelines, including those related to child-resistant packaging and tamper-evident features, to ensure that all packaging solutions comply with the necessary standards for the markets they will enter.
Yes, we can support the packaging needs of products for global markets. Our team has extensive experience with the regulatory and logistical challenges of international packaging requirements, including multi-language labeling, serialization for track and trace compliance, and adapting packaging materials and formats to meet the preferences and regulations of different countries. We work closely with our clients to develop packaging solutions that facilitate global market access.
To ensure product stability during packaging, we take several measures, including selecting appropriate packaging materials that offer protection against moisture, light, oxygen, and other environmental factors. Our packaging processes are designed to minimize exposure to conditions that could degrade the product, and we conduct stability testing on packaged products to verify that they maintain their integrity, efficacy, and safety throughout their shelf life.
The packaging of temperature-sensitive products involves using specialized materials and technologies to maintain the required temperature conditions. This can include insulated packaging, cold chain logistics, and temperature monitors to track conditions during storage and transportation. Our facilities are equipped to handle temperature-controlled packaging processes, ensuring that temperature-sensitive products are protected from temperature excursions that could affect their quality.
Yes, we provide serialization and aggregation services for drug products to meet global track and trace regulations. Our serialization solutions include the application of unique identifiers to each package, aggregation of serialized packages into larger shipping units, and integration with supply chain management systems to ensure traceability from manufacturing through to the point of dispense. We help our clients comply with regulatory requirements for anti-counterfeiting and supply chain security.
Yes, we offer child-resistant and senior-friendly packaging options to ensure the safety and accessibility of drug products. Our child-resistant packaging designs comply with regulatory standards for preventing accidental ingestion by children, while our senior-friendly packaging solutions are designed for easy opening and use by older adults, without compromising safety. We work with clients to select and design packaging that meets the needs of their target patient populations.
We ensure the quality and integrity of the packaging process through strict adherence to cGMP standards, regular quality audits, and continuous monitoring of packaging lines. Our quality control measures include visual inspections, leak testing, and verification of labeling accuracy to ensure that every package meets our high standards for quality, safety, and compliance. Our facilities are equipped with state-of-the-art packaging equipment, and our staff are extensively trained in best packaging practices.
Yes, we can handle the packaging of high-potency and cytotoxic drug products. Our facilities are designed with dedicated areas and containment technologies for handling potent compounds safely. We implement strict protocols to protect our staff and prevent cross-contamination, ensuring that these products are packaged safely and in compliance with regulatory guidelines for handling hazardous materials.
Our approach to sustainable and eco-friendly packaging involves using recyclable or biodegradable materials, minimizing packaging waste, and optimizing packaging designs to reduce environmental impact. We collaborate with suppliers who share our commitment to sustainability and continuously explore innovative packaging solutions that meet our clients' needs while supporting environmental conservation. We're dedicated to reducing the carbon footprint of our packaging processes and contributing to a more sustainable pharmaceutical industry.