Marketing Authorisation

Marketing Authorisation - Qualified Support

Projects in clinical product development including marketing authorisation are both personnel intensive and time consuming. For many years now Dr. Oestreich + Partner GmbH has provided competent support for the realisation of successful marketing authorisations.

Our team, comprising numerous experts in various scientific fields, prepares all the necessary documents for your marketing authorisation. At the same time, we advise you on budgeting and financial management issues and contact all key personnel in a timely fashion. We monitor clinical trials (Phases I to IV), create and edit the necessary case report forms (CRFs) or files (eCRF). Moreover, depending on the requirements of the clinical studies, they may be performed in our own multi-disciplinary medical centre.

Marketing Authorization with Internet-based Documentation Systems

During the entire marketing authorisation project, real-time access to the current status of all study data, without the need to be physically on site at the investigational site, is enabled through our web-EDC systems OPVERDI and PMSBOX. Individual and multilingual versions of electronic CRFs can be created with the data bases, into which the results of special investigations such as laboratory tests or imaging procedures (ultrasound, CT, etc.) can be integrated.

As required our highly qualified staff creates and translate medical texts for a variety of specialist areas. These include CRFs or eCRF, applications for regulatory approval for marketing authorisation, documentation for doctors, study protocols, clinical study reports and so forth.

We are a full-service contract research organisation (CRO) that, on behalf of our customers, successfully meets the increasing demands on clinical research projects and the numerous legal and regulatory requirements. In our training facilities, we hold regular events on various topics for staff from research, quality assurance, and marketing and distribution backgrounds. We tailor the content according to the requirements of the participants. Moreover, we offer targeted seminars and practical training for monitors, doctors, pharmacists, pharmaceutical representatives and patients amongst others.

Please click here for a comprehensive overview of our services in clinical research and marketing authorisation!

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