Pharmaceutical Development – a comprehensive, interdisciplinary solution
The work of our Department covers a broad range of functions:
- Formulation development of solid and non-solid formulations from laboratory to production scale (new development, reformulation, line extension). More about the relevant technologies and equipment can be found here.
- Process optimisation
- Support of pharmaceuticals production operations in case of formulation issues (trouble shooting)
- Product transfer
- Production of stability samples in compliance with applicable GMP guidelines
- Manufacture of investigational medical products for clinical trials supplies (Phase I to IV)
- Project and cost management
- Generation of pharmaceutical industry appropriate documentation and of documents for regulatory approval worldwide
- Training of pharmaceutical production technicians, chemical laboratory assistants and pharmacist trainees
Our mission is formulation development of solid and non-solid dosage forms - we identify the optimum dosage form including the appropriate manufacturing process for each active pharmaceutical ingredient.
Based on our knowledge and long-term experience of all fundamental pharmaceutical processes and the respective technical equipment of our department we are able to develop completely new or to reformulate existing drug products (optimization, line extension) for internal projects or in accordance with our customers’ requirements.
Our focus and our core competence cover not only special technologies such as microtablet manufacturing, a technique established at Nordmark since the mid-1980s, but more particularly, the processing of biological and biotechnological active pharmaceutical ingredients, such as pancreatin and collagenase. A major advantage is our interdisciplinary collaboration between departments, in particular with our colleagues from the Process Development area (active pharmaceutical ingredients). Generally speaking, the short physical and hierarchical distances in our company enable a constant exchange with the specialists in other departments and are a significant component of our success.