Business areas
We are also happy to support you in the development and creation of regulatory documents and are available to you as a competent partner for all questions relating to active pharmaceutical ingredients (APIs).
We adapt to your needs and are also available for individual services.
We strive for trust-based cooperation through open communication. When discussing how to solve problems, we show a high degree of flexibility and we are pleased to accommodate your wishes when designing the cooperation.
We support you with all questions regarding
- synthesis development, scale-up and GMP manufacturing of active pharmaceutical ingredients including analytical method development and GMP quality control;
- synthesis, establishment and control of reference substances;
- synthesis development and GMP manufacturing of active ingredients for clinical samples;
- synthesis of isotopically labelled substances for in-vitro diagnostics;
- development of purification processes for active pharmaceutical ingredients based on our patented HAPIpur® technology (fully automated continuous multi-stage counter-current crystallization);
- development of shaping processes (particle design / particle engineering) for active pharmaceutical ingredients for targeted pharmaceutical application on the basis of constructive physical processes;
- creation of regulatory relevant documents, such as ASMF, IMPD, CEP;
- creation of safety data sheets according to REACH TRGS 220 and other documents relevant to hazardous substances, and
- general handling of active pharmaceutical ingredients.