In order to import products in the field of pharmaceutical substances from countries outside of the EU, a batch certification (QP Release) is needed. The product that is to be imported is handed a batch certification to ensure that it follows the GMP standard and holds the right documentations for this. Thereby the substance can be approved to be manufactured in third countries, like Switzerland, New Zealand, Norway and Japan, which have separate laws and rules from the EU. So, to be able to import these products, carry out clinical trials, or market a new medical product, the batch certification is a must.
ClinStorage has been approved to perform batch certifications since 2011, which is when we were also GMP certified.
Batch certification is only one part of what ClinStorage does. We take the task of handling, storing and distributing samples very seriously, and with many years of experience behind us, we are good at what we’re doing. We handle the storage of test samples by GMP and GDP standards, which means that all materials are treated correctly according to its specified needs, and 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 your samples have certain needs outside of what has already been mentioned, we are happy to adapt all handling, transportation and storing of your materials to the demands at hand, all for an easy and risk-free storing.
Having batch certification on our list of merits makes ClinStorage the perfect partner when you need to transport, handle and store pharmaceutical materials, as we aim to make the whole experience as simple and risk-free as possible for our customers, taking care of every step on the way. You are welcome to contact us if you have any questions!
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