Field of expertise:	Pharmaceutical, analytical and galenical development
Founded in:	1995 (Amtsgericht Charlottenburg, HRB 55 301)
Managing Directors and Owners:	Rudy Thoma and Dr. Christian Brätter
Employees:	8
Turn over:	~1 Mio €
Core activities:	Formulation of pharmaceutical products: solid, liquid and injectable forms Lyophilization technology GMP-Quality control of starting material, packaging material, intermediate, bulk and finished products Manufacturing licence in accordance with §13 AMG Manufacturing of clinical supplies in accordance with §13 AMWHV Analytical release of clinical supplies and medicinal products in accordance with §14 AMWHV Release for market or clinical study in accordance with §16 AMWHV Import and EU-release of clinical supplies, comparator products and medicinal products manufactured in non-EU countries (§72 AMG) External Inspection by Qualified Person of pharmaceutical manufacturers (API and medicinal products) Screening of packaging materials Up scaling and validation of processes Development and validation of analytical methods (CPMP) Storage of API, clinical supplies and medicinal products in climatic chambers: 25°C, 60% RH, 30°C, 65% RH, 40°C, 75% RH, 5°C and storage at custom specified conditions Stability testing and in-use stability (CPMP/ICH) On-going stability (GMP-conditions) Quality documentation (CTD Module 3) Support in regulatory affairs Development of nutrition supplement products Synthesis of drug substances Purification, isolation and identification of degradation products in medicinal products and drug substances Synthesis of special radioactive compounds