Is your product a medicinal product, a medical device, or both?

Determining which legislation a product falls under is essential. When the question of which legislation applies to a product is not unequivocal, the term borderline products is used.


What is a PRRC and why is it necessary to have one when the new MD Regulation enters into force?

One of the most significant new regulatory provisions is related to the increased requirements for internal monitoring by companies, namely the designation of a Person Responsible for Regulatory Compliance (PRRC).


The MD Regulation is entering into force – is your quality management system in order?

If your company works in the field of medical devices, it is important for you to know that the new Medical Devices Regulation (MDR, EU 2017/745) requires all manufacturers of medical devices to have a quality management system.


Reporting of adverse drug reactions protects users of pharmaceutical products

Adverse reactions are carefully monitored in clinical trials before a drug enters the market, and after that they remain under constant monitoring throughout the life cycle of the drug. Every report on adverse drug reactions is important for the evaluation of the safety and efficacy of a drug.


Pharmaceutical production is not set up overnight

new pharmaceutical production is not set up by clicking fingers. The process is slow and multi-stage, and everything is done in the name of patient safety.


COVID-19 vaccine: 10 years of work in 10 months, how was this possible?

Read our expert blog how was it possible to develop a safe and effective vaccine within this timeline.


When two become one: The merger of pharmaceutical companies always creates turmoil behind the scenes

Mergers of pharmaceutical companies always involve big changes and difficult decisions. What should be done with the role of the responsible person when there will only be one position left after the merger? Read about our thoughts on the topic on our blog.


A typical day in the life of a consultant (even in emergency conditions)

Emergency conditions or not, we move forward with our daily lives. Amidst the meetings, processing, and consultation, we always make time for a quick online coffee meet-up.


Ensuring availability of medicines amidst the coronavirus crisis requires flexibility

How are we ensuring availability in Finland today, and what more could we do? See our blog for a list of measures in place.


When the patient is in charge – thoughts at a pharmacy’s OTC shelves

Customers often head for a pharmacy also in matters not involving prescription medicines, and the selection of OTC medicines seems dizzying even to a pharmaceutical professional.


Why pharmacies run short of medicines – should we be worried?

Issues related to availability of medicines have been in the headlines in all over Europe.


What if you could read a package leaflet without a magnifying glass – and the leaflet also gave you advice?

In future, the package leaflet may be an electronic smart document which reminds you to take your pill or to renew a prescription.

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