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Blogs | 24.01.2023

Biological medicines: how does their manufacturing process differ from traditional medicines?

The differences in the manufacturing process and the nature of the active substance itself mean that biologicals differ from traditional medicines in many ways.

Blogs | 28.11.2022

Crisis-tolerant security of medicine supply

DRA Consulting has conducted an extensive preliminary report on the operating environment of the medicine supply chain, commissioned by the healthcare pool that operates under the National Emergency Supply Agency.

Blogs | 24.10.2022

From an independent company to part of PharmaLex Group – how it all happened

When a company reaches a certain size and a certain level of maturity, the investors and other industry operators start to show interest. That is what happened to us too.

Blogs | 11.08.2022

Cooperation will make the Nordic region an attractive pharmaceutical market

In the global pharmaceutical market, the individual Nordic countries are very small. Together, they are much larger, but still relatively lightweight. This is certainly true if you look purely at sales volumes.

Blogs | 01.06.2022

There is strength in numbers – DRA crowdsources visioning of the future

Last year, we engaged all of our 100-plus employees in the organisation’s strategy work and visioning the future. This way, we managed to harness the silent knowledge of all our employees for the company’s foresight process, and by crowdsourcing, we also future-proofed our strategy.

Blogs | 01.05.2022

One month till the new dawn – EU IVDR will be applied in full in May 2022

In this blog post, our Health Tech Team Leader Tiina Riihimäki provides an overview of the latest developments and the foreseeable challenges in the process. Read her expert advice on how to prepare for this historic legislative change.

Blogs | 28.04.2022

DRA Driving Responsible Action

What does responsibility mean to you? What would you set as your goal for social responsibility in 2022? These are some of the questions that all DRA’s employees were asked in the beginning of this year.

Blogs | 30.09.2021

Five tips for the reference price jungle

You need to be familiar with the Finnish reference price system in order to submit price notifications appropriately and on schedule. At worst, forgetting to submit price notification may lead to the medicinal product losing its reimbursability.

Blogs | 28.09.2021

Assessing the biological safety is a measure that protects both the user and manufacturer of a medical device.

The process for biological hazard identification and risk assessment is called biological safety evaluation. Often this means an evaluation and testing process based on the ISO 10993 standard.

Blogs | 14.09.2021

The Camino de Hope campaign challenges DRA employees to start exercising

The idea of the challenge is to clock up 1,000 kilometres in a year without any help from motors. Many DRA employees took up the challenge, and we were also able to involve our customers.

Blogs | 30.08.2021

MD/IVD Regulation causes changes to national legislation in EU member states

A new Finnish national legislation has entered into force.

Blogs | 17.08.2021

Sales is undergoing major changes: from personal selling to hybrid selling led by COVID-19

Experiences in successful adaptation of B2B service selling during these exceptional times.

Blogs | 12.08.2021

Mode of action defines whether your product is a medicinal product or a medical device

Medicinal products and medical devices alike can be used to diagnose, prevent, treat, and alleviate diseases, or to correct, restore or modify physiological processes.

Blogs | 08.06.2021

Do you know which designation codes are applicable to medical devices manufactured by your company?

When a manufacturer applies for conformity assessment from a notified body (NB), the type of devices and technologies subject to conformity assessment activities are to be indicated using designation codes.

Blogs | 08.06.2021

Notified Body – A business-critical relationship

Long-lasting relationships with notified bodies (NBs) are important and also business critical for many medical device manufacturers.

Blogs | 26.05.2021

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.

Blogs | 20.05.2021

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).

Blogs | 11.05.2021

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.

Blogs | 18.03.2021

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.

Blogs | 16.02.2021

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.

Blogs | 08.12.2020

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.

Blogs | 23.09.2020

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.

Blogs | 08.05.2020

Category: Blogs