Consulting Services Pharma: Investigational Medicinal Products, Clinical Trial Materials, Production, Regulatory Affairs
We advise young and established pharmaceutical and biotech companies during the planning of a first production of a new medicinal drug product as well as during transfer projects of a drug product from one production facility to another. We offer to coordinate your formulation development projects, to implement a production of clinical trial materials (e.g., Investigational Medicinal Products) at a Contract Manufacturing Organisation (CMO) and also your first commercial production at your supplier of commercial products. Our strength is project management to implement your product at the chosen manufacturing site which can be your own site or indeed another CMO anywhere in the world.
- You avoid timely delays and late notice changes of your production activities.
- You avoid additional cost by keeping to scheduled and realistic timelines.
Our long-term experience in contract manufacturing and contract research and development as well as the expertise collected during the implementation of new products at manufacturing facilities ensures that our customers and partners get the best support.
Our in depth experience in projects for the international markets - Europe, USA, Japan, ROW - is of advantage for the planning of regulatory activities to support the entrance of your products into these markets. We can support you during the complete regulatory process until approval of your product for the market.
We are familiar with the regulatory requirements for the EMEA, the FDA and the Japanese authorities. Together with our partners in Germany, USA or Japan we push your applications forward in these countries.
We support chemical companies during production and development projects with a professional project management to ensure that projects become reality. We also have experience in the field of food supplements.