Which are the business segments of Evidentic?
Evidentic is a supply specialist for pharmaceutical reference (medicinal) products, so-called RMPs, used along the entire value chain of pharmaceutical development. For the comparability exercise we supply historic batches of RMPs from different batch runs. For the later stages of pharmaceutical development, we supply RMPs for authorization phase and finally for clinical trials.
Our goal is to help to reduce the complexity of sourcing RMPs for our clients and as a result to help speed up the development of new biosimilar products.
What is an RMP?
Reference medicinal products (RMPs) are finished pharmaceutical products, or medicines, that have a market authorization and are distributed through a network of manufacturers, pharmaceutical wholesalers or pharmacies. The reference product is used throughout the biosimilarity exercise to compare different product characteristics to the API under development.
What are Evidentic’s a-RMPs?
Once an RMP is procured and received at Evidentic, the product undergoes quality control at our GDP-certified storage facility. In a second step this quality control step is repeated at our GMP-certified facility.
The product than undergoes a standardized aliquotation procedure in a GMP-certified laboratory. Following this high-quality procedure, the analytical-RMPs – now called a-RMP – are stored at the conditions as recommended by the original manufacturer or alternatively stored at -80°C.
How many milligrams of an API does each a-RMP contain?
The amount of API provided for a specific a-RMP vial is listed in the product table. In most cases, each a-RMP aliquot will contain 2-6 mg API. Concentrations of all a-RMPs remain unchanged from the original product.
How many microliter does each a-RMP contain?
Usually a volume between 40 to 400 µl are contained in an a-RMP vial and is depended on the on the concentration of the original reference product and the total amount of API transferred into the vial.
What are the storage conditions of the a-RMPs aliquots?
All a-RMPs are stored in a GMP-class laboratory according to the original manufacturers storage conditions. Upon expiry of a batch the storage conditions are adjusted to maintain the integrity of the API and are deep-frozen to -80°C.
Who can order a-RMPs from Evidentic?
The product portfolio of Evidentic is indented for clients in the biosimilar industry, governmental or other non-for-profit research laboratories, clinical research organizations or any related institution.
For regulatory purposes we treat a-RMP as genuine pharmaceuticals. For our sales process that means that Evidentic is obliged to qualify its clients. Clients holding a GMP-certificate or a wholesale dealer license (WDL) qualify directly for procurement at Evidentic.
How can I purchase a-RMPs from Evidentic?
It’s very straightforward: go to Evidentic’s product page (link) and choose your product of interest. Click on the desired product and choose the batch and required quantity. Continue the process until you have found all the a-RMP batches you like to use for your experiment. You will receive a summary of your product inquiry, including batch information and prices. In some instances, prices can only be confirmed after you get in contact with us. Finally, a quotation will be send to your E-mail address.
Why can I not directly order online from your web shop?
Evidentic is a business-to-business solution provider to the pharmaceutical industry and to non-commercial institutions. For regulatory reasons, we are obliged to qualify our customers before the first transaction can be completed. This qualification process requires documentation that may differ between commercial and non-commercial institutions. Once the registration process was completed, the procurement can commence. This process is required only once for new customers.
Which documents do I need for the qualification process?
Commercial customers need either a pharmaceutical wholesale dealer license or alternatively a GMP manufacturing license.
Non-commercial institutions such as laboratories or universities should demonstrate that their institutions is registered with their local authority. For example, analytical laboratories can provide a GMP certificate, which would qualify for registration.