Companies in the pharmaceutical industry – chemical and biotechnological manufacturers of original preparations as well as generics – are increasingly operating in an area of tension between rising costs and high demands from a wide range of stakeholders. It is often difficult to meet the demands of suppliers, investors, customers (patients, clinics, pharmacies) and the public (society, authorities, state) and at the same time to act economically. In addition, there are high regulatory requirements such as the German Medicines Act and GMP regulations (EU GMP Guide/EU GMP Annexe, FDA CFR Title 21, ICH International Conference on Harmonization).
In order to take into account the current changes and ensure sustainable success, traditional processes need to be re-examined.
While research-based pharmaceutical companies focus primarily on their product pipeline and R&D processes play a central role in the company, generic companies need to convert expiring patents into marketable products as quickly and efficiently as possible and to produce cost-effectively.
With more than 25 years of experience as well as numerous successfully implemented projects, we understand the challenges of our clients in the pharmaceutical industry and have developed our own methods and tools to specifically address these and support our clients in ensuring patient safety.
We have built up deep industry and process know-how and advise along the entire product life cycle: