Importing medicines to EU requires certain certifications to be in order. A batch release and certification (QP Release) is given by the QP (qualified person). The QP is responsible for the product that is to be imported, and makes sure it meets all requirements. With a QP release/batch certification, approval can be given to manufacture a substance in third countries, like Switzerland, New Zealand, Norway and Japan, which have separate laws and rules from the EU. So, when importing medicines to EU, it is now ensured that the product follows the GMP standard and holds the right documentations for this. To be able to import these products, carry out clinical trials, or market a new medical produce, the QP release/batch certification is a must.
ClinStorage has been approved to perform QP releases since 2011, which is when it was also GMP certified. But this is only a small part of what we do, and we have many years of experience in handling, storing and distributing materials. Handling the storing of samples by GMP and GDP standards means that we take great care to treat all materials correctly according to their own specially defined needs. It also means that we follow strict regulations to keep the samples in storage safe from any potential threats. You can read more about how we work at clinstorage.se.
If you choose to work with ClinStorage when importing medicines to EU, you have the perfect partner for transporting, handling and storing pharmaceutical materials, as our goal is to make the whole process as simple and pain free as possible for our customers. We take care of every step on the way, and making importing medicines to EU run smoothly is of great importance to us. You are welcome to contact us if you have any questions about importing medicines to EU!
Safe and secure storage
ClinStorage provides safe and secure storage facility according to GMP standard for your valuable biological samples and pharmaceutical substances/products. The GMP standards are applicable for GLP and GCP samples.
Storage, from room temperature down to -150º C and LN2. Dispensing and packaging, with sample management. Transportation and cold chain logistics. Batch release and certification (QP Release).
The storage service includes high security with facility access control and temperature monitored 24/7, including power backup. We offer comprehensive “one-stop-shop” services related to storage and distribution.
ClinStorage AB, a privately owned public company, was founded and is led by Ola Camber, PhD, Assoc Prof and Sven Jacobsson PhD, Prof. Both have together more than half a century of experience from the pharmaceutical industry such as Pharmacia, AstraZeneca and Biotech companies.
Based on their experiences within assignments in big and small pharma they discovered an imminent need for freeze storage services.
ClinStorage is providing safe and compliant storage of valuable materials at defined conditions such as low and ultra low temperatures.
GMP certified by the Swedish Medical Products Agency
ClinStorage provides unique quality service with in depth knowledge, making us ideal partner for clients’ entire need for storage, release and distribution.
- Storage of for example medicinal and investigational products, plasma, tissues and cells
- Wholesale distributor for medicinal and investigational products
- Batch release and certification (QP Release)
- Import and batch release of medicinal and investigational
- products from 3rd countries
- GMP audits