Algol Pharma Oy Karapellontie 6, FI-02610 Espoo, Finland
SWEDEN Algol Pharma AB Isafjordsgatan 36,SE-164 40 Kista,Sweden
- 1 Overview
- 2 CORPORATE RESPONSIBILITY
- 3 PHARMACOVIGILANCE
Algol Pharma is an international healthcare company headquartered in Sweden. In our business we value the close and confidential relationships with our customers and partners. Discover our services and see how we can together help providing the prerequisites for healthy and longer living.
YOUR INNOVATIVE HEALTHCARE PARTNER - PROMOTING WELLBEING TOGETHER
Algol Pharma is a healthcare company active in (but not limited to) the Nordic and Baltic markets. We import, export, market and sell prescription, hospital and OTC pharmaceuticals, as well as free trade products. We also provide a comprehensive range of pharmaceutical services for companies in the industry.
All operations are guided by the commonly agreed objectives and the values that are important to the company.
VISIONWe are the most efficient and innovative service organisation and most desired partner for our customers and suppliers.
Your innovative healthcare partner, promoting wellbeing together.
Accountability Collaboration Development
Operations are based on responsibility and the trust of our customers. The quality of the customer experience is a matter of honour for us, one in which we always strive to offer service that exceeds expectations.
Since 1993 Algol Pharma’s operations have been certified according to the ISO 9001 quality standard. Since 2012 our operations have also complied with the demands of the ISO 14001 environmental standard. Within the framework of our quality control system we ensure Good Distribution Practice (GDP) in our wholesale pharmaceutical activities and full compliance with the regulatory requirements for pharmacovigilance activities.
In our marketing activities we are committed to applying the Pharma Industry Finland Code of Ethics. Algol Pharma is a member of Pharma Industry Finland (Lääketeollisuus ry), which supervises the interests of the Finland-based pharmaceutical industry
Seeking for assistance in complying with pharmacovigilance legislation or implementing the quality system? Do you require manpower to handle all your reporting needs? Are you lacking a Qualified Person for Pharmacovigilance (QPPV), a Local Drug Safety Officer (LDSO) or a Medical Advisor?
Answer is: contact us!
Our pharmacovigilance services are available throughout the all Nordic and Baltic markets.
ESTABLISHMENT AND MAINTENANCE OF PHARMACOVIGILANCE SYSTEMS
- Maintaining the pharmacovigilance system of your products throughout the entire lifecycle.
- Case Management: the processing of product safety information on your behalf, including:
- maintaining the product safety register
- processing (incl. MedDRA coding) and reporting electronically
- providing medical evaluation and signalling (risk-benefit evaluation)
- archiving documents appropriately
- narrative writing.
- Literature surveillance and review: literature published internationally (Medline), locally and documentation / processing Medical Literature Screening results in case of your product safety information
- Medical writing: compiling and maintaining any required pharmacovigilance documentation, including:
- Pharmacovigilance System Master Files (PSMF)
- Periodic Safety Update Reports (PSUR) in PBREP format
- Risk Management Plans (RMP)
- Clinical Overviews
- Signal Detection (risk-benefit evaluation)
- Regulatory Intelligence – keep up to date with regulatory guidelines and amendments to legislation
- Contact towards authorities on your behalf
GOOD PHARMACOVIGILANCE PRACTICES (GVP)
Our experts can plan and establish an effective pharmacovigilance quality system for your company that includes Pharmacovigilance System Master Files (PSMF), Standard Operating Procedures (SOP), annual internal audits, annual pharmacovigilance training and orientation training. We can also supply guidelines for planning pharmacovigilance quality indicators and monitoring compliance.
REGISTRATION AND MAINTENANCE OF EUDRAVIGILANCE DATA
Our qualified and certified staff can help registration and maintaining your data in the EVWEB electronic database of the European Medicines Agency, for example by registering your products in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and making sure the information is kept up to date. In addition, we can handle the Electronic Transmission of Individual Case Safety Reports (E2B).
We provide advanced training and mentoring for experienced experts, as well as orientation training for new experts for handling registration tasks. We also offer an innovative approach to annual training events, as well as pharmacovigilance training for new employees.
We offer expert medical translation services in all languages – fast and flexibly!