Our Expertise & services
Our expertise in a nutshell
- Contract Manufacturing & custom syntheses on cGMP level
- Collaborative R&D including process optimisation
- Regulatory and patent support
- Scale up from grams to commercial scale manufacture
- Legal support respecting intellectual property
- Information flow and technology transfer with regular reports incl. impurity samples, analytical methods, stability studies, scientific documentation, etc
- Development & validation of analytical procedures
Our performance in a nutshell
Seamless drug development from lead to market
In the early steps we supply quickly the needed amount to run the pre-clinical phases including phase I and II. Meanwhile we may help with the process research.
Once your product progressed to the advanced phases we provide you with the necessary support to optimise the process. We are capable of supplying the increased amounts of your drug - everything under cGMP.
| Legal, patent and regulatory support Process Safety |
|||||
| Research | Pre-clinic | Phase I | Phase II | Phase II | Market |
|---|---|---|---|---|---|
| Process Research | |||||
| Rapid supply of cGMP API | |||||
| Process Development / Optimisation | |||||
| Manufacture of API acc. to cGMP | |||||
As a matter of fact, we provide process safety and our legal, patent or regulatory affairs do accompany the entire collaboration with you.
In order to guarantee this rapid and flexible processing of your requirements and needs we perform a project based approach.
Where and how exactly do we support you?
With a direct contact to the customer Medichem is committed to science, quality and speed.
We know that today’s drug development processes are under a high pressure regarding time and money. We focus on accompanying our customers to help them to reduce both the costs and the time to bring their product to the market. For this reason we established a project based approach.
Project management - first phase:
The communication starts with the client contacting Medichem. During this communication we define your intentions and needs as precisely as possible. In order to protect your interests a CDA is signed before we get into a deeper conversation and exchange of information.
When the technical package is submitted to us for internal review all departments involved will give feedback to that. Within 2 days we will decide whether Medichem is capable or not to support you with this enquiry.
When we are capable to support you all colleagues from our technical team and R&D will meet with you during telecons or meetings to exchange information and ideas. 
Within 3 to 5 days Medichem delivers a quote with the required information, timelines and prices. Additionally, we provide a summary of the meetings in form of a report.
If necessary we may have a further meeting or telecon to discuss our proposal and fix all items for the project.
Project management - second phase:
If you - the client - are happy with the outlined project we follow your placed order.
We provide you a Project Package that contains all necessary information about the outline of the project. Apart from that a project manager will be appointed. The project manager will head your project, manage your enquiry internally and will be responsible for keeping agreed timelines and milestones during the whole lifecycle of your project. The project manager will be your individual contact person. 
Our project management guarantees a rapid and flexible processing of your requirements and needs: From the enquiry right through to the assistance in legal, patent or regulatory issues, such as i.e. filing of a Drug Master File.
