SOLVING CAPACITY AND TIME BOTTLENECKS WITH CDMO

Arevipharma is a reliable and established CDMO partner of many large and medium-sized pharmaceutical customers. Contract manufacturing projects have been an integral part of our business activities for over 20 years. As a medium-sized company, we are characterized by short decision processes, maximum flexibility for our customers and fast project processing.

Project process

For us, the processing of a CDMO project includes the following milestones in the project plan, which can be adapted as desired depending on the requirements of our customers.
  1. Feasibility study

    Projects begin with a feasibility study on a laboratory scale. Within the scope of this, either the customer's synthesis is examined for its general adaptability and scalability, or it is developed in a basic manner within the scope of development.
  2. Development

    This is followed by the chemical development of the process and, in parallel, the development of all the necessary analytics. The aim is to investigate the synthesis in detail and optimize it for production on an industrial scale.
  3. Validation/ Transfer

    The process is validated when the developed process is transferred to our production plant. Five plants of different volume classes are available to our customers.
  4. Stability programm

    Following the validation, the stability studies are performed according to ICHQ1 and according to the storage conditions requested by the customer.
  5. Regulatory Affairs

    Our regulatory team prepares regulatory documentation for any desired global pharmaceutical market on behalf of the customer. Our customers can always choose whether they want to be the marketing authorization holder themselves or Arevipharma.
  6. Commercialization

    After successful completion of the validation and obtaining all desired approvals, we transfer the project to routine commercial production. The product is then managed by our Sales Operations and Supply Chain team. With five different sized production facilities, we can also support the commercialization of the product at any time in the product life cycle with scalability of production volumes.
  7. Logistics

    Numerous storage options for many substance and hazard classes and temperature ranges are available at the Radebeul site. Arevipharma handles the logistics of our CDMO products either under its own responsibility or on behalf of qualified third-party warehouses.

Project management

Our customers are supported in their CDMO project by a dedicated project manager who is in the lead for all external and internal communications. Our project managers have many years of experience in the API industry and a chemical background, which always ensures reliable, technically sound and customer-specific support for our CDMO partners. Behind the responsible project manager we have a team of representatives from all departments who handle the project internally. Due to the high relevance of CDMO projects for Arevipharma, sufficient capacities are always available in development as well as quality assurance, regulatory affairs and production.

As a medium-sized company with quick decisions, we are always able to accompany our customers reliably, bindingly and expeditious through all project stages.

We are happy to advise you

We are looking forward to your inquiry
regarding our active ingredient portfolio or your CDMO project.