Consulting and Planning

The success of a project starts from the initial talks. Thanks to our many years of experience, and our outstanding expertise in finding solutions, we are among the best in the industry.
With our cooperative client relationship and our detailed and reliable consulting, we build the fundamental basis for the trust that our clients shown in us.
We take the time to understand your requirements in detail and implement these with the necessary sensitivity and a keen sense of urgency. Together with you, we find the optimal design of work packages for the respective development phases and provide a binding offer. Short reaction times distinguish us, as well as the development of individual solutions.

Project Management

As a CDMO your projects receive our full attention. Every member of our team, with the knowledge and skills required, is actively committed to the success of your project. Being close to our clients is not just a promise, but a core behavior at Rentschler. We are convinced that the trust required to successfully complete a project is underpinned by an open and cooperative atmosphere. To ensure a close, regular exchange, we assign a scientifically qualified project manager to each client project who is responsible for managing all aspects of the project, including monitoring the timeline, goals and budget.

Regulatory Support

Our constant monitoring of regulatory environments and our experience in approval strategies and in the creation of approval documents at an international level ensures that your product is documented in accordance with regulatory requirements. By working with us from the beginning we know your project and can support you from the cell to the vial through to the approval dossier for market and clinical studies.
We advise and assist you with regulatory questions, develop optimized strategies and generate the complete documentation for approval (IND/IMPD CMC parts, Module 3 BLA/NDA/MAA). We are able to draw on our experience with various products such as "orphan drugs" or biosimilars.