DRA Consulting Oy is an independent employee-owned Finnish consultancy in the pharmaceutical regulatory affairs. We are in co-operation with over 250 pharmaceutical companies.It is the trusted partner of more than 250 pharmaceutical companies in Europe.
In the eyes of clients, our key strengths are solid experience, reliability, solution orientation and flexibility.
We are an industry trailblazer with a thorough understanding of the entire life cycle of medicinal products. Our mission is to find the fastest route to success for our clients. Working as a strategic partner allows us to fully employ our know-how to benefit the client and support all aspects of their business.
Thanks to our staff of more than 60 experts, we can offer flexible resourcing solutions and back-up personnel even at short notice.
We are a founding member of EuDRAcon, the pan-European network of independent service providers in the pharmaceutical industry.
|Headquarters|| Pakkalankuja 7
01510 Vantaa, Finland
|Number of employees||51-200|
- Regulatory Services
- Medical Translation
- Pharmaceutical Wholesale
- Pharmaceutical and Chemical services
- Promotional reviews
- Price and Reimbursement
- Medical Services
- Consultation and Training
- Borderline Products
- Personnel leasing
Is the management of daily pharmacovigilance activities too resource-intensive? Do you occasionally need special expertise?
We offer easy and efficient access to pharmacovigilance services, including up-to-date information on pharmacovigilance requirements and other topical issues. Our team helps ensure you stay on course at all times.
Examples of our services:
- Serving as pharmacovigilance specialists and/or qualified persons for pharmacovigilance (QPPV)
- Medical assessment and MedDRA classification of adverse reactions, electronic reporting of adverse reactions to the EudraVigilance system
- Global medical literature monitoring, local medical literature monitoring in the Nordic region
- Monitoring of risk-benefit ratios, signal detection and management
- Preparation and maintenance of Pharmacovigilance System Master Files (PSMF)
- Preparation of risk management plans (RMP) and implementation of measures
- Preparation of Periodic Safety Update Reports (PSUR)
- Medical support
- Submission of medicinal product information (Article 57 and ISO IDMP) to the EudraVigilance database, including real-time maintenance of information
- Monitoring of regulatory guidelines and requirements.
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