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