Pharmaceutical Manufacturing ·
Expertise in Pharma Research & Development, Manufacturing, Project and Life Cycle Management with specific expertise for Oncology, cardiovascular, CNS, diagnostics, male and female hormonal therapies, dermatology All kinds of small molecules incl. highly potent drugs, radiopharmaceuticals and biologicals (incl. antibodies, proteins, cell and gene therapy) All types of conventional dosage forms, drug delivery and application systems as well as packaging concepts IP generation and defense Preclinical and clinical pharmacokinetics Quality control and bioanalytical concepts Trial medication supply GXP and Quality assurance Change management Training and coaching Services Program and project evaluation for all types of Pharma R&D and Life Cycle Management activities Due diligence for acquisition and in-licensing projects Evaluation and consultancy with special emphasis on biopharmaceutical, pharmacokinetic and CMC (Chemistry, Manufacturing and Control) issues incl. technical transfer assessment IVIVC Project management activities incl. CRO-selection and outsourcing management Independent scientific assessment and expert opinion statements Scientific and technical support at customer site Training, development and educational programs at customer site QP support Organisational development activities efficiency and process analyses design concepts benchmark analyses implementation support Change management projects