WHO WE ARE
An experienced CRO team offering integrated solutions in Contract Research, Development and Analytical services for the Pharmaceutical industry.

What we do

From concept design to project completion – turnkey solutions from one source

We provide complete solutions for your research and development projects to promote your research topics and projects in the clinical API development of small molecules and nanoparticulated non-biological complex drugs (NBCD’s).

Our focus is to develop robust, scalable and economic synthesis and production processes. Our analytical capabilities span from R&D stage to release analysis of commercial products under GMP conditions.

We are dedicated to deliver the highest quality of contract service to support our customers from large international firms to smaller Biopharma companies in the best possible way with our experience, flexibility and passion.    

Our professional project leaders offer efficient, reliable and pragmatic support from initiation, planning and controlling to the successful completion of a project. We can ensure the most effective way of achieving your goals. Our management processes are tailor-made to meet your requirements and organization culture.

WHAT WE CAN PROVIDE YOU WITH

Custom synthesis and process development – Analytical Services – Consulting

Process Optimization

Optimization of lab scale processes by QbD and support of tech transfer to production scale including in-process analysis development

Method development

Development and validation of analytical methods including transfer (GMP compliant). Alternatively verification of monography or customer methods for QC release analysis of raw materials, intermediates, active pharmaceutical ingredients (APIs) and drug products

Synthesis

Synthesis and analytical characterization of reference standards

Forced degradation studies

Forced degradation studies, also known as Strss Stability Studies of API’s (Active Pharmaceutical Ingredients) or FDF’s (Finished Drug Formulations), to predict impurities development during the storage under different environmental conditions. Testing of acidic and basic hydrolysis, oxidation, thermal degradation and photostability according to ICH Q1B.

NBCD characterization

Physico-chemical characterization of nanoparticulated non-biological complex drugs (NBCD’s) and cannabinoids

Analytical Services

Comprehensive range of analytical services in Liquid and Gas Chromatography, Elemental analysis, Polymer analysis, Thermoanalytical methods, Wet Chemistry, Titrations, Spectroscopic and Spectrometric analytical methods

Our Clients

Our services for leading brands like