The GMP compliance certificate was firstly issued in the End of 2008. In the End of 2012 our Drug Agency has re-audited us and has prolonged our certificate, which also allows us the GMP-regulated production of one antiviral generic API.
We have also successfully passed many GMP-compliance customers audits. The most recent audit occurred in April 2014. Our GMP system and compliance to the regulations were actually highly praised, and this is the result of several years work and improvement.
Generally, there are two options.
Option 1 is to work on the FTE-basis. In case of process development or complicated synthesis development (unknown compounds etc), this is the preferable option for us. Our FTE includes work of one chemist and basic chemicals and basic analysis (HPLC, NMR, TLC etc). Cost for basic chemicals and basic analysis should not exceed 10% of FTE cost. FTE cost does not cover any special chemicals (which are sometimes quite expensive, catalysts etc) or some additional analyses (AAS, elemental analysis etc).
Option 2 is the fixed price work per compound. The conditions may vary case by case. Normally we do the fixed price work only if the synthesis is already known for us or we do not consider the risk too high.
• All the Intellectual Property belongs to the Customer;
• The Customer receives a weekly report on the progress of the Project;
• A phone conferences will be arranged once per week (at least or upon the wish of the Customer);
• Customer can stop the project at every moment, paying only for the man-hours delivered (FTE basis), special chemicals and special analyses);
• The invoices are generated on the 2-weekly or monthly basis;
• At the End of the Project (or on the monthly basis if necessary), the customer will receive the Final Report (Study Report), including all the experimental data (NMR, HPLC, HRMS, MALDI-MS, LC/MS etc) and full experimental descriptions.
We prefer to work on the CDA basis. It is easier for us, and therefore more secure for the Customer. Exclusivity can be described in the contract or CDA. E.g., if the CDA is signed on the compounds not to be disclosed (or any other information, e.g. manufacturing process description), they will never be disclosed. That is why the best way is to start with CDA.
Our general sales terms and conditions may be found here.
Security of data transfer is achieved by the following:
• Encrypted emails – both our incoming and sent e-mails are encrypted with SSL;
• Secure server – we only use a locally accessible Windows fileserver with user account access restrictions;
• Hardcopy versions via postal services – CDAs, contract copies, CMC documentations are normally sent by DHL or TNT services.
Both the contract services and API production are to be performed at our own site in Tartu Biotechnology Park. We do not have any other foreign sites and we do not outsource manufacturing to other organizations.