Each batch of an original drug is purchased by a procurement specialist from qualified wholesalers or directly from the manufacturer. A continuous temperature-controlled transport process also guarantees correct storage conditions at every stage of the logistics process. Our GDP-certified storage facilities are regularly inspected by local authorities to ensure the high drug storage standards you expect from a pharmaceutical supplier. The subsequent process of manufacturing drug aliquots is performed by a biopharma analytical specialist with more than 20 years of experience in sample preparation for analytical analysis. All products are stored at -80°C to maintain the stability of the proteins over a longer storage period.
We perform a GDP-compliant sourcing including all pedigree information for our clients (photos of all originally packaging are available upon request).
We provide an Aliquot Data Sheet (ADS) which includes the purchase date, origin (EU), transportation and storage conditions during GDP transportation/storage, aliquotation date and the storage temperature of the resulting aliquots. Please check here an example of the ADS under www.evidentic.com/downloads/, Evidentic business information, Example Aliquot Data Sheet (ADS).
A Certificate of Analysis (CoA) is an official document from the original pharmaceutical product (RMP), issued by the manufacturer of the medicinal product. It contains information on some critical quality characteristics of the medicine. CoAs are available only for some medicines and limited batches. Customers can order the medicinal product CoA together with the aliquots of the same batch. If you would like to purchase a CoA for a specific aliquot, please download the list of the available products with CoA Drug Aliquots with CoA – Pricelist. As Evidentic does not perform analytical tests on the drug aliquots, all CoAs available through Evidentic are from the original pharmaceutical product (RMP).
For licensed pharmaceutical products the Certificates of Analysis (CoA) are issued with each new batch that is supplied to the market. But this is not compulsory for all products and markets that is why they are not always available. All pharmaceutical products are licensed by an international or national authority, the manufacturing processes, quality and safety guidelines for each product are always submitted to the authority before the marketing authorisation is granted to the manufacturer. In Europe, EMA (European Medicines Agency) is the regulatory authority with which all EU medicines are registered. During the registration process, the applicant submits all necessary documents to assess the safety and efficacy of the manufacturing process. Detailed information on many aspects of the manufacturing, handling, storage and distribution process is kept at EMA that then assigns an EU registration number under which each product can be uniquely identified.
Once the authority agency has granted the applicant the manufacturing and distribution rights, all processes described to them must be maintained and followed. However, the holder of the manufacturing and distribution licence (authorisation) is not obliged to provide further documentation when reselling his medicines to hospitals, wholesalers or pharmacies. This includes the certificate of analysis. The manufacturer is free to provide a CoA to the customer.
Unfortunately the probability of obtaining CoAs for products that we do not trade is very low. But you can always buy retrospectively the CoAs of the products that you have bought already from us (in case they are available) or just the CoAs without the need of buying the aliquot as well.