PRODUCTION AND SERVICESTechnology and Laboratories
Technology & Laboratories
Developing process for manufacturing API as CRO.
The following technologies and equipment are present in our laboratories:
Calorimeter (Optimax)
Hydrogenator
Low temperature reactions (-90° C)
Purification via automated chromatographic columns
HPLC and UPLC systems (UV-VIS, diode array, RI detector)
GC systems (HS, FID and MS detector)
DSC, PXRD, particle size distribution
Karl Fischer titrator
Automatic titrator
Optical microscope
Additionally: IS, UV, polarimeter, NMR
Our laboratories
Quality & Regulatory
Producing all the technical and regulatory documentation to support our customers in drug development up to the filing of authorization requests (e.g. NDA, ANDA) with the competent authorities.
The following technologies and equipment are present in our laboratories:
Product dossier (PD)
Porject Proposal
Technical Package
Process Master Formula (PMF)
Chemistry Manufacturing Controls (CMC)
Drug Master File (DMF)
Intellectual property
Providing support for patent evaluation/survey and freedom to operate (FTO)