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 and diluted 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 according to the original manufacturer’s conditions or at -86°C to maintain the stability of the proteins over a longer storage period. Which documentation do you provide?
We perform a GDP-compliant sourcing including all pedigree information for our clients (photos of all originally packs)
We provide an Aliquote Datasheet (ADS) with purchase date, origin (EU), transportation and storage conditions during GDP transportation/storage, aliquotation date and the storage temperature of the resulting aRMP tubes.
A Certificate of Analysis (CoA) is an official document issued by the manufacturer of the medicinal product. It contains information on some critical quality characteristics of the medicine. CoA’s 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 see the CoA product page. 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 Certificates of Analysis (CoAs) are issues with each new batch that is supplied to the market. As pharmaceutical products are licensed by an international or national authority the manufacturing processes and quality + safety guidelines for each product are submitted to the authority before a marketing authorisation is granted to the manufacturer. In Europe, the 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 the Agency. The Agency assigns an EU registration number under which each product can be uniquely identified. Once the Agency has granted the applicant manufacturing and distribution rights, all processes described to the Agency 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.
We work together with a large network of pharmaceutical suppliers. In some cases it will be possible to obtain CoAs products that you have purchased from a source other than Evidentic. However, all CoAs that Evidenic can offer for our own products will be shown on the CoA product page – in other words: what you see is what you get!
We can also advise you for which products CoAs are available in Europe and for which products this is generally not possible. Just ask us!