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."

A general overview of our range of services in drug licensing can be found here - Click here!

EMA Pharmacovigilance
Health care studies
Observational studies
EMA Pharmacovigilance
Medical Biometrics
Approval of Medical Devices
Clinical Investigators
Clinical Trials
GCP Legislation
GCP - Good Clinical Practice
GCP Guidelines
GCP Compliance
Clinical Research Organisation
Contract Research Organisation
Pharmacoeconomics, Health
Pharmacoeconomic studies
Patient Monitoring
Monitoring Clinical Trials
Clinical Monitor
Marketing Authorisation
Medicinal Product Approval
Drug safety
Data management plan
Clinical development
Monitoring investigators
Non-interventional studies (NIS)
Patient recruitment
Phase IV studies
Investigator audit
Investigator qualification
Investigator selection

EMA Pharmacovigilance · Health care studies · Observational studies · EMA Pharmacovigilance · Medical Biometrics · Approval of Medical Devices · Pharmacovigilance · Clinical Investigators · Clinical Trials · GCP Legislation · GCP - Good Clinical Practice · ICH GCP E6 · GCP Guidelines · GCP Compliance · BfArM GCP · Clinical Research Organisation · Contract Research Organisation · PSUR · PSURs · Pharmacoeconomics, Health · Pharmacoeconomic studies · Pharmacoeconomics · Patient Monitoring · Monitoring Clinical Trials · Clinical Monitor · Marketing Authorisation · Medicinal Product Approval · Drug safety · Data management plan · Clinical development · Monitoring investigators · Non-interventional studies (NIS) · Patient recruitment · Phase IV studies · Investigator audit · Investigator qualification · Investigator selection