At EarlyHealth Group, we understand that the success of your global clinical trials hinges on precise, compliant, and efficient packaging and labeling within a short period of time.
We offer comprehensive clinical trial packaging and labeling services that are fully compliant with EU GMP regulations, ensuring your trials run smoothly from start to finish. Our goal is to provide customized solutions that save you time and offer flexibility for any sudden changes in your packaging and labeling requirements.
For clinical trials, whether you need open-label, blinded, or expiry extensions in GMP packaging (production), or just-in-time (JIT), EarlyHealth ensures extremely fast turnaround times. We focus on reducing overage and eliminating waste, adapting swiftly to last-minute changes, and providing tailored documentation for each clinical trial site location.
WHY CHOOSE OUR CLINICAL TRIAL PACKAGING AND LABELING SERVICES?
- Short Timeline from Request for Proposal (RFP) to study start up
We are able to provide a detailed proposal for your packaging and labeling requirements within 5 working days, and book in a suitable production slot within 60 working days. - EU GMP compliance and regulatory expertise:
Our processes adhere strictly to EU GMP regulations, guaranteeing the highest standards of quality and safety. In-depth knowledge of regulatory requirements across different regions, minimizing the risk of compliance issues. All steps of our packaging and labeling procedures are carefully monitored and approved by our team of Qualified Persons (QPs).
- Custom Solutions:
Tailored packaging and labeling solutions to meet the specific needs of your clinical trials, from small-scale studies to large, multinational trials. We make sure to find the most appropriate solution to fit all variations to ensure the easiest handling by your chosen Health Care Professionals (HCPs).
OUR EXPERTISE
Primary and
Secondary Packaging
From blister packs and bottles to cartons and kits, we handle all your packaging needs. Our packaging solutions are designed to ensure product integrity and patient safety. We provide scalable packaging options to meet the demands of your growing clinical trials.
Label Design and
IMP Kit Production
Customized labels that meet regulatory requirements and ensure clear, accurate information. Avoiding high waste by surplus of patient kits including ancillaries due to a tailored kit production dedicated to EU GMP compliance. Our label designs enhance readability and compliance, ensuring seamless integration with your clinical trial protocols.
Blinding and
Randomization
Secure processes to maintain trial integrity and minimize clinical trial bias. Precise and documented procedures to ensure smooth blinded or double blinded and randomized multicenter trials on a global basis. Our robust systems prevent bias and maintain the credibility of your trial results, supporting successful regulatory submissions.
Regulatory
Documentation
Comprehensive documentation of the whole packaging and labeling process to support regulatory submissions and audits. We ensure all documentation meets regulatory standards, facilitating smooth approval processes. Our detailed records enhance transparency and traceability, providing you with confidence in compliance.
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