Clinical Services
Safe handling throughout the clinical trial process.
At Herlev Pharma Service, we provide specialised solutions for every stage of clinical trials – from storage and transport to regulatory support.
With extensive experience and a flexible approach, we ensure the safe and compliant handling of your clinical products throughout the entire process.
Connecting CMC, Development, and GMP
Herlev Pharma Service bridges the gap between CMC, development activities, and GMP by providing comprehensive, regulatory-compliant services across the entire value chain – from development to production and delivery. This helps ensure that your clinical trials and product development consistently meet the highest standards of quality and safety.
From Import to Clinical Trial
We support you throughout the entire process – from import and clinical packaging to storage, release, and transport.
01
Import & Regulatory Management
We manage the import process, including the necessary licences and customs clearance, ensuring compliance with applicable regulatory requirements.
02
Clinical Packaging & Labelling
We package and label clinical products in accordance with the study protocol and regulatory requirements.
03
GMP Storage
We store clinical products under GMP-approved conditions with temperature control and full traceability.
04
QP Release & EU Testing
We coordinate QP release and EU testing for products imported from third countries, ensuring a compliant process.
05
Validated Transport
We provide validated, temperature-controlled transport solutions for the safe delivery of clinical products.
Supporting GMP at Every Stage
GMP is at the core of our approach. We ensure that your products are stored, handled, and transported in accordance with the highest quality standards. This includes:
- GMP-approved storage facilities with full temperature control and traceability.
- Validated transport solutions with documented temperature control and security.
- Regulatory compliance throughout the supply chain – from import to final destination.
Flexible and Validated Transport Solutions
We continually qualify and approve new carriers, ensuring that we always have two to three validated solutions available. This enables us to select the best solution based on your specific needs, project timelines, and budget while ensuring that GMP requirements are met throughout the process, including during temperature-controlled transport.
QP Release and EU Testing
For products imported from third countries, we support the entire QP release and EU testing process, ensuring that the products meet all regulatory requirements before being used in clinical trials.
Looking for a Partner for Your Clinical Trial?
Let’s discuss your needs and identify the right solution for handling your clinical products.