Associated Consulting Activities
With our active commitment and professional advice, every project with Rentschler Biopharma is in expert hands. Our experience in approval strategies at an international level ensures that your product is documented in accordance with regulatory requirements.
Consulting and Planning
We already set the course for a successful project in our initial interactions.
Thanks to our many years of experience and our outstanding expertise in finding solutions, we are among the leaders 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 put 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. In collaboration with you, we find the optimal design of work packages for the respective development phases and provide a binding offer. Short reaction times as well as the development of individual solutions set us apart.
As a global leading CDMO, we give our full attention to your projects. Every member of our team possesses the knowledge and skills required and 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 Biopharma. We are convinced that the trust required to successfully complete a project is underpinned by an open and cooperative atmosphere. We assign a scientifically qualified project manager to each client project to ensure a close, regular exchange. All along your project, the project manager assumes complete project control, including monitoring of timelines, goals and budget.
Our constant monitoring of regulatory environments and our experience in approval strategies as well as 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 early conception stages, we know your project and can support you from concept to market, including approval dossiers.
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 draw on our experience with various products, including orphan drugs or biosimilars.