Pharmacovigilance

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Pharmacovigilance

Benefit from our conscientious way of working.

For more than 20 years, the team of Dr. Notghi Contract Research GmbH has been providing full regulatory services in pharmacovigilance for pharmaceutical companies. We take over local and global literature searches, the preparation of periodic safety reports and risk management plans, and the preparation and maintenance of your pharmacovigilance system master file. Both during the conduct of clinical studies and after approval, we are a reliable service partner for you. Benefit from our conscientious way of working.

Let us advise you

🇬🇧 German

Full-Service CRO – our services

Case processing

The team of Dr. Notghi Contract Research GmbH takes care of data entry, MedDRA coding, evaluation and reporting of side effects, SAE for you. We offer you extensive experience in dealing with various databases. Do you have any questions about our services? We are also happy to be at your disposal in person.

Literature screening

The team of Dr. Notghi Contract Research GmbH takes over the necessary literature searches for you. We are happy to support you in the selection of suitable specialist literature. We evaluate the information of the Medical Literature Monitoring (MLM) service of the European Medicines Agency for you.

Safety reports

The team of Dr. Notghi Contract Research GmbH prepares periodic safety reports (PSURs) and risk management plans (RMP) for you. The services include, among other things, literature searches, analyses of company-specific data and the assessment of expected risks. We will advise you on the regulatory procedure and prepare the complete documents for submission on request.

Consulting

Our experts provide you with comprehensive advice on regulatory issues. In addition to our support in setting up a PV system, we prepare you for inspections and audits. We support you in ongoing referral procedures and the preparation of red-hand letters and officially mandated training materials.

Training

Together with the Dr. Notghi Academy, we have been training specialists in pharmacovigilance for ten years. Our experts provide you with comprehensive and practical knowledge on regulatory basics to current and specific expertise.

Our services

Selection of relevant specialist literature (print & online media)
Regular literature screening including individual case processing
MLM evaluation
Literature searches
Analysis of company-specific data
Benefit-risk assessment
Submission according to EURD list
Quality controls of the documents

Our expertise

20 years in the conduct of clinical studies & trials
15 years in pharmacovigilance and drug safety
10 years in the publication of study data

Your advantages

Reliable services
Short communication channels
Broad competence for complex projects

Working together

Eye level & trust
All-round view & forward thinking
Discreet & direct

Do you have any questions about our services? We are also happy to be at your disposal in person.

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Pharmacovigilance