Ropack brings unique expertise to the manufacturing and packaging of clinical trial materials. As clinical trial protocols have become increasingly complicated, Ropack has fine-tuned its processes and updated its equipment to stay on the leading edge. We efficiently track the amount of doses and duration, monitor rapid growth within emerging regions and provide sophisticated supply chain control. Our facilities are flexible and visible, allowing extended control of GMP activities, from protocol design to the investigator site.
Ropack’s client service management approach delivers specific skills early in the planning stages to design efficient packaging configurations and create multilingual labelling. Our superior inventory control ensures the receipt, packaging, storage and distribution of clinical trial materials. And quality assurance (QA) teams support every project to ensure that standard operating procedures (SOPs) and good manufacturing practices (cGMP) are rigorously executed to meet the standards of regulatory agencies.
Starting with the protocol interpretation and design, we will guide you through the planning phase of the clinical protocol to ensure that the right packaging is designed for maximum patient compliance and product shelf life. It is a critical step to bring cost-effectiveness into your clinical supply chain. From manufacturing to packaging, and ultimately distribution of investigational products, our services support every single detail of your clinical supply chain efficiently and cost-effectively.
Our collaboration with a contract formulation and process development service company (Corealis Pharma) means that we can offer development of pharmaceutical solid dosage forms for a complete range of pharmaceutical solid dosage forms (tablets, capsules and granules) for the manufacturing of clinical and commercial lots. Our service even extends to the complex paperwork required by regulatory agencies. We assist in the completion and submission of relevant documents and submission of documents required for the transfer and transit of the products to a large-scale manufacturing site.
Our manufacturing and packaging services include:
- Over-encapsulation
- Manufacturing of placebos
- Blending
- De-printing
- Primary packaging for blister strips / sealed card and bottles
- Secondary packaging
- Translation services and multi-lingual labelling
- Comparator sourcing
- Drug return
- Accountability and destruction services
Our storage and distribution facilities deliver clinical supplies worldwide and our client services management teams, positioned throughout our network, control clinical supply chains most effectively. A significant benefit is our network of facilities with controlled refrigerated and ambient temperatures. In clinical studies IVRS systems (interactive voice response systems) increase accuracy and efficiency of clinical trials while reducing costs.
At Ropack, we value our culture of innovation and continuous improvement. We welcome the opportunity to manufacture and package materials for your next clinical trial. Contact us to discuss your requirements.