Medicinal Product Approval
Medicinal product Approval - Competent Support
medicinal product approval requires careful project planning, which is oriented to timelines and milestones. Dr. Oestreich + Partner GmbH offers a comprehensive service package for successful medicinal product approval in Europe. As a full service company, we support our customers from the initial planning of the drug approval process; at an early stage, we network the necessary key positions and maintain a full overview of the process to ensure efficient, structured and scientifically-sound work. We undertake the compilation and preparation of all documents required for drug approval and the monitoring of ongoing clinical trials (Phase I to IV). Clinical trials may also be conducted in our own multi-disciplinary medical centre, depending on the subject area.
medicinal product approval with the Support of Internet-based Documentation Systems
We also prepare case report forms (CRF) for studies for drug registration and, with our internet-based EDC systems OPVERDI and PMSBOX, we provide flexible software solutions for the preparation of individual and multilingual eCRFs. These databases also allow the integration of specialised investigations such as ECG, laboratory tests or imaging procedures (CT, ultrasound, etc.). The ready access to all relevant data provides you with an up-to-date overview, without a visit to the investigational site being necessary.
Through our product registration team, we provide you with highly qualified and experienced staff for a variety of medical disciplines. The team prepares medical texts, and as required, carries out multilingual translations of study protocols, reports, documentation for physicians, templates for investigator contracts, reports on product safety or regulatory applications for drug approval.
In our training centre in Cologne, we stage events addressing a variety of different subjects for personnel with research, marketing and sales backgrounds. We additionally hold seminars to include training on drug approval and we organise internships. Our technically experienced coaches and instructors also teach subjects such as "Good Clinical Practice" in accordance with the EU and FDA, and "Quality Assurance Measures in Clinical Research."