Solutions for API customers
Aevus is an API supplier. We provide integral services around the API supply development project and we do this through our Project Management Office. These services include among others, the location and/or selection of manufacturer, due diligence, contracts and agreements procurement, documentation management, quality audits, regulatory affairs and technical and regulatory consulting.
Our product portafolio comes from manufacturing sites approved by reference regulatory agencies and contains products with solid technical dossiers. Our products include monoclonal antibodies, recombinant proteins and therapeutic enzymes.
All of our services can be provided individually or will be part of the complete supply development project.
Commercial
Intelligence
Location of APIs and DPs supply sources and consolidation of new supply partners.
Due Dilligence
Evaluation of the manufacturer and manufacturing site. Including Quality Management System, production, supply capacity, regulatory compliance and execution of site audits.
Contracts & Agreements
Commercial contracts Quality agreements Services agreements
Regulatory Affairs
Support throughout the regulatory process for product registration. Support for the assembly of documental packages and technical and regulatory consulting.
Project Management Office
Management of the new supply development project through our Project Management Office. Project Management support during product development and after product commercialization.
All of our services can be provided individually or will be part of the complete supply development project.
Commercial Intelligence
Location of APIs and DPs supply sources and consolidation of new supply partners.
Due Dilligence
Evaluation of the manufacturer and manufacturing site. Including Quality Management System, production, supply capacity, regulatory compliance and execution of site audits.
Contracts & Agreements
Commercial contracts Quality agreements Services agreements
Regulatory Affairs
Support throughout the regulatory process for product registration. Support for the assembly of documental packages and technical and regulatory consulting.
Project Management Office
Management of the new supply development project through our Project Management Office. Project Management support during product development and after product commercialization
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