Articles & News

The Medical Device Regulation is significantly changing the regulatory framework for medical devices in Europe. One of the new major challenges is the increased focus on post-market surveillance. This forces pharmaceutical companies to be more proactiv

On-site audits can be replaced by well-organized remote auditing. There is a need for frequent auditing in Pharma business. Most of these audits can be carried out remotely. Document reviews and interviews can easily be conducted remotely. When remote

CE marking is an indicator of a medical device’s compliance with EU legislation. CE mark on a medical device is an indication of the manufacturer’s verification that the device complies with all relevant and essential requirements (such as safety and p

Webinars take place every Thursday at 14:00 – 15:00 (EEST) starting from 28th May until 18th June 2020. Why to Join? The purpose of this webinar series is to give oversight of the updated medical device regulation, including the latest updates. To Whom

Tervetuloa keskustelemaan COVID-19 pandemian vaikutuksista lääkkeiden hyviin jakelutapoihin (GDP)  Torstaina 14.5.2020 klo 11:00 – 12:00 Toteutustapa: Microsoft Teams webinaari   Keskustelutilaisuuden aiheena COVID-19 tilanteen hallinnointi GDP:n

Medical Devices and upcoming new regulations on Thursday 14.5.2020 at 14:00 – 15:00 (GMT+3) Why to Join? The purpose of this webinar series is to give oversight of the updated medical device regulation, including the latest updates. To Whom? This serie

Medical writing requires specific expertise Medical writing involves writing scientific documents of different types, which include but are not limited to, regulatory and research-related documents, drug-related educational and promotional literature,

Medical Device Services draw on Biocodex’s long and extensive experience and leading expertise in pharmaceuticals and medical services. Currently, Biocodex provides expert services to over 130 pharmaceutical companies in the Nordic and Baltic countries

Jenni Kononoff (PhD, MPharm) has been appointed as Medical Manager and Jonas Hinkkanen as Head of Regulatory Affairs for Biocodex Pharmaceutical and Medical Services (PhaMe). Jenni Kononoff is an experienced researcher and pharmacologist, who has a tot

Biocodex PhaMe employees will be out of office on 10th April 2020 due to Good Friday and on 13th April on the Second Easter Day. During the holidays, we would like to remind you to contact us by using our common mailboxes whenever applicable: Pharmacov

Check out our new position Regulatory Affairs Specialist and apply soon!   Updated 24th of March 2020: The application for Regulatory Affairs Specialist is now closed and we thank all the applicants for their interest in the position. Candidates w

Instead of sending Christmas cards Biocodex has donated this money to Red Cross. The donation will help victims of natural disasters and conflicts both in Finland and around the world.

DOA gets closer! What does it mean? What changes? The requirements for clinical evaluation applies also for Class I Medical Devices. Clinical evaluation involves the assessment and analysis of clinical data pertaining to a medical device to verify the

NOTE! The event is conducted in Finnish. OHJELMA 8:30   Hyvän Olon aamiainen 9:00   Tervetuloa! 9:10   Kokemuksia lääkevarmennusjärjestelmän käyttöönotosta   Lääkevarmennus eri apteekkijärjestelmissä. Miltä hälytykset näyttävät ? Kehittämispäällik

Summer holiday season is nearby. We would kindly remind you that we are available the whole summer season and our back-up system is in place. To ensure fluent and smooth information flow during holiday season, please use our common mailboxes whenever a