Yes. The GMP compliance certificate was firstly issued in the end of 2008 and was prolonged afterwards as result of many audits by the State Agency of Medicines. The GMP certificate covers manufacturing of non-sterile active pharmaceutical ingredients by chemical synthesis. The GMP certificate was also expanded to the QA&QC lab and manufacturing of pre-formulations for clinical trials. We have also successfully passed many GMP-compliance customers audits.
Generally, there are three options.
Option 1 is to work on the FTE-basis (full time equivalent). In case of process development or synthesis of novel compounds, this is the preferable option for us. Our FTE includes work of one chemist, basic chemicals and basic analysis (HPLC, NMR). Cost for basic chemicals and basic analysis should not exceed 5% of FTE cost. FTE cost does not cover any special chemicals (which are sometimes quite expensive) or any additional analyses (AAS, elemental analysis etc).
Option 2 is the fixed price per compound. The conditions may vary case by case. Normally we offer the fixed price only if already know the synthesis or we do not consider the risk too high.
Option 3 is a combination of short feasibility study (offered at fixed price) and estimation of the production costs. After the feasibility study is carried out and we are sure the synthetic route actually works, we will recalculate the production costs.
- All the Intellectual Property belongs to the Customer;
- The Customer receives a weekly or biweekly progress report;
- Telecons or Skype calls are arranged once per week or two weeks
- Customer can stop the project with 2 weeks notice, compensating us only the man-hours delivered (FTE basis), special chemicals and special analyses;
- The invoices are generated on the monthly basis;
- In the end of the project, 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 NDA (CDA) basis. It is easier for us, and therefore more secure for the Customer. Exclusivity can be described in the contract or NDA. E.g., if the NDA 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 NDA.
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.
The API manufacturing is to be performed at our own site in Tartu Biotechnology Park. We do not have any other foreign sites and we do not outsource API manufacturing to other organizations.