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

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.

News | 13.12.2022

EU Council to postpone the MDR deadlines

The commission’s plan would not automatically apply an extended transitional period for all the medical devices, but the extension would be allowed on the condition that it is critical for the safety of the patients.

News | 12.12.2022

Our team of great colleagues has grown again

We are proud to introduce our new team of experts

News | 08.12.2022

This Christmas we give gifts to the Baltic Sea

With our Christmas donation, we support the activities of the John Nurminen Foundation to save the Baltic Sea and its heritage.

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.

Cases | 08.11.2022

New COVID‑19 vaccine swiftly launched to the market in tight timeline

Company prepared the launch of vaccine in extremely tight timeline. They needed help to prepare linguistically and medically correct product information texts in extremely tight timeline.

News | 27.10.2022

Market Access Expert, Nordic Market Access team 

Our Nordic Market Access team is growing, and we are looking for an additional team member to join us in Finland.

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.

News | 15.09.2022

Our expert team grows

DRA’s expert team grows even stronger. We are pleased to announce the addition of new top talents to our ranks.

Cases | 08.09.2022

Success in medicinal product dossier preparation for global markets

When developing a new medicinal product, our client opted for a global approach: they wanted to access all the major markets, and to benefit from synergy, they decided to prepare the CMC documentation for the EU, FDA and Japan authorities simultaneously.

News | 01.09.2022

DRA was founded 20 years ago

DRA Consulting was founded 20 years ago on 1st September 2002. We have always wanted to share our expertise and take part in social actions having impact on society. We hope that our actions will generate motivation, creative solutions, joy at work and well-being for others as well.

News | 22.08.2022

Use the promotion code DRA20 for the trainings organised by the Finnish Pharmaceutical Information Centre 

In celebration of DRA’s 20th anniversary, we can now offer a 20 % discount on the regular price of the trainings to our clients and partners.

News | 16.08.2022

Our growth story continues – DRA Consulting to become part of the PharmaLex Group

DRA and PharmaLex are merging to create a centre of pharma and Health Tech expertise with nearly 3,000 experts. The merger will bring synergies for the customers of both companies while helping to accelerate Nordic cooperation in the pharmaceutical market.

News | 15.08.2022

Press Release: PharmaLex expands Nordic footprint across key business units with DRA Consulting merger

PharmaLex expands Nordic footprint across key business units with DRA Consulting merger

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.

Cases | 02.08.2022

New drug substances manufacturing site GMP certified thanks to DRA’s expertise

A client started getting prepared for the authority inspection. Soon they realised that they lacked both expertise and resources in building up a new GMP qualified manufacturing site for drug substances.

News | 02.06.2022

A sneak peek to the future: ÄLY seminar puts the spotlight on finnish innovations and solutions for sustainable drug development

In this year’s ÄLY seminar organised by DRA, the discussion turned around different future visions about green pharmacy, corporate social responsibility, the latest innovations in health technology and the possibilities that quantum technology can offer for drug development.

News | 01.06.2022

DADI webinar: What will happen at go-live

The first web-based form to be released in the DADI project is a variations form for human medicinal products, and it is still expected to go live in October 2022.

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.

News | 31.05.2022

Three new guidance documents related to IVD medical devices available

Three guidance documents regarding in vitro diagnostic medical devices were published in May by the Medical Devices Coordination Group (MDCG).

News | 30.05.2022

New experts to join DRA – call for more talents still ongoing

DRA keeps growing! Warmly welcome Virve and Maura.

News | 26.05.2022

Is it a drug or a device? A useful guidance document on borderline products available

The Medical Device Coordination Group (MDCG) has provided guidance on how to better identify the borderline between a medical device and a drug.

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.

News | 28.03.2022

The Medical Device Coordination Group (MDCG) has provided guidance on the appropriate surveillance regarding legacy devices

Some devices may still be placed on the EU markets under the Medical Devices Directives as so-called legacy devices.

News | 28.03.2022

New talents to DRA’s diverse expert teams

Welcome to DRA Hanna Ridderheim, Solja Kalha, Elisa Saarnio ja Henna Torvi!

News | 01.02.2022

A new innovation that makes placing medicinal products on the market quicker and saves money

Press Release: A Finnish company is digitalising the process of writing marketing authorisation applications – the sections describing the medicinal product’s manufacturing and quality can be completed in half the time with the new DRA Variator® software. 

News | 31.01.2022

It is a pleasure to introduce our new experts

Welcome Moona, Pauliina, Nina and Joona!

News | 31.01.2022

The extension to the transition period of the IVD Regulation (EU) 2017/746 is now official

On 28th of January 2022, the European Commission published in the Official Journal of the European Union an amending regulation as regarding to the transitional provisions of the in vitro diagnostic medical device (IVD) regulation for certain IVD medi

News | 28.01.2022

Application of the Veterinary Medicines Regulation to begin

The Veterinary Medicines Regulation (2019/6) will be applied as-is in all EU Member States from 28 January 2022. The Regulation will lead to changes in the pharmacovigilance, distribution and marketing of veterinary medicinal products, as well as applying for marketing authorisation and maintaining it.

News | 17.12.2021

Gift to the sustainable future and green pharmacy

We made a donation to the sustainable pharmacy fund of the University of Helsinki and the new professorship. With this donation, we want to support the establishment of the world’s first professorship in sustainable development in pharmacy.

News | 12.10.2021

DRA welcomes new professionals

DRA continues to grow and we are proud to introduce our new team of experts. Welcome Henna Juvonen, Elsi Tuominen, Militsa Kukko, Roosa Bäck, Pia Mustakangas, Jasmin Pyrhönen ja Vilhelmiina Peltoniemi.

News | 11.10.2021

Swedish SPC approved for less than 50% of human medicinal products

Fimea reminds marketing authorisation and registration holders of the requirement to submit a Swedish Summary of Product characteristics by 9 February 2022.

News | 11.10.2021

The use of EMA’s Organisation Management Services (OMS) data is extended

The latest application form version has been published on 1 October 2021 and the use of the form and OMS information is mandatory from 1 November 2021.

News | 11.10.2021

The validity of GMP and GDP certificates are extended until the end of 2022.

The European Commission, EMA and the European medicines regulatory network has updated the activities to ensure the availability of medicines during COVID-19 pandemic.

News | 06.10.2021

MDCG has released guidance for classification of medical devices

The document provides practical examples of devices, including applicable rules and classifications.

News | 06.10.2021

The device and certification module of EUDAMED is now open for registration and searches!

The EUDAMED device module was launched across the Europe on 4 October 2021, but the transition periods are defined on national level.

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.

News | 07.09.2021

DRA’s organisation is developing – Jussi Rysä has been appointed Unit Head

His responsibilities in DRA’s operations are Market Access, Marketing Compliance and Medical Services, Pharmacovigilance and Language and Communications Services.

News | 03.09.2021

DRA joins effort to establish the world’s first professorship in sustainable development in pharmacy in Finland

We want to promote actions that can effectively reduce environmental impact of pharmaceutical manufacturing and the different stages of medicinal product’s life cycle.

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.

News | 25.08.2021

MDCG has released guidance for performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVD) 

The content of released guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months. 

News | 25.08.2021

The Finnish Medicines Agency FIMEA has issued a new administrative regulation on economical operator and device registrations for medical devices 

The new regulation implements the obligations set out in medical device EU-regulations (2017/745 and 2017/746) and in national legislation 719/2021 in Finland. 

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.

News | 29.06.2021

Guidance published by EU-commission on obligations and related rules for the registration in EUDAMED

To guide registration activities, EU-Commission has released a Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorized representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR in June.

News | 29.06.2021

SWIXIT – Effects on the current status of the EU-Switzerland mutual recognition agreement (MRA) for medical devices markets

These should be noted by Swiss medical device manufacturers and legal manufacturer with Swiss Notified body or Swiss-based Authorized Representative.

News | 29.06.2021

Experienced experts and fresh top performers join our DRA team

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.

News | 02.06.2021

Our Health Technology expertise is increasing further

Tiina Riihimäki, PhD (Medical Technology), has been appointed as Health Technology Team Leader at DRA.

News | 02.06.2021

Electronic product information – where are we at?

When it comes to electronic product information, a central question is the patient’s digital health information literacy. At the moment, there is electronic product information available, but the challenge is how accessible and easy-to-find it is.

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.

News | 25.05.2021

Zero day MRP/RUP in Iceland

IMA has published a new guideline on the Zero Day MRP/RUP process (in Icelandic).

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).

News | 18.05.2021

Cycling Day 2021 – doing good for the benefit of young people’s mental health

The charitable exercise day will take place on 19 May.

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.

News | 10.05.2021

CMDh: Dexamethasone for the treatment of COVID-19

CMDh has published a summary RMP for medicinal products containing dexamethasone for the treatment of COVID-19.

News | 03.05.2021

Download a guide on the certification and licencing of Life Science products

The guide describe the essential regulatory requirements in Finland and in the EU.

News | 12.04.2021

It is a pleasure to introduce our new experts

Welcome Malena, Adele, Carita, Santtu-Matti, Jussi, Katri and Miika!

News | 07.04.2021

The Swedish Medicines Agency (MPA) is proposing increases in fees

On March 2, 2021, the MPA has proposed to the Swedish government an increase in fees for control of medicinal products as of January 1, 2022. The reason for the increases is mentioned e.g. increase in operating costs.

News | 07.04.2021

Guideline on Nordic Packages and Q&A document updated

The Nordic Co-operation Group has updated the Guideline on common Nordic packaging materials and the Q&A document. Four new questions have been added to the Q&A document. Some of the existing questions/answers have also been updated.

News | 01.04.2021

EU Digital Application Dataset Integration (DADI) – new eAF formats

A new IT project called the Digital Application Dataset Integration (DADI) has been launched in the EU.

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.

News | 17.03.2021

EMA Medical terms simplifier

EMA has published Medical terms simplifier – a list of plain-language descriptions of medical terms commonly used in information about medicines.

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.

News | 15.02.2021

Monitoring the adverse reactions of COVID-19 vaccines

On January 27, 2021, Fimea opened a website for adverse reaction reports for coronavirus vaccines. The page is updated more than once a week by the number and severity of adverse reaction reports.

News | 10.02.2021

Great talents joining DRA

Get to know the experts of our growing team. Welcome to Outi, Jaana, Katariina ja Soile.

News | 15.01.2021

International cooperation in evaluating COVID-19 vaccines and drug therapies

EMA has launched a new OPEN pilot to increase international cooperation in evaluating COVID-19 vaccines and drug therapies. The project started in December 2020.

News | 15.01.2021

First notified body approved in Finland

Fimea has approved the first notified body under the new Medical Devices Regulation (MDR), SGS Fimko Oy, in Finland.

News | 21.12.2020

Our team of great colleagues has grown again

Pharmacist specialising in industrial pharmacy Linda Tossavainen-Nikki, MBA and B.Sc. (Pharm.), and pharmacist Anna-Kaisa Tuderman,  M.Sc. (Pharm), are joining our regulatory services team. Sami Tyrjy B.Sc. (Pharm.) has started as a new employee in our sales and marketing team.

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.

News | 26.11.2020

Pharmacovigilance now and in the future – Current topics of the World Drug Safety Congress Europe

Future trends were emphasised strongly in the discussion, especially with regard to the development possibilities introduced by new technological solutions. Read the highlights of the event.

News | 16.11.2020

DRA takes part in the ISPOR Europe 2020 

News | 05.10.2020

Growing business requires new kinds of experts

Outi Järvinen, has started work as Head of Resourcing and Accounts in DRA’s sales and marketing team.

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.

News | 19.09.2020

DRA welcomes new professionals

Get to know the experts of our growing team. Welcome to Pia, Virpi, Heli, Stina, Vilhelmiina, Riina and all three Heidi.

News | 17.09.2020

Combining exercise, fun, and charity – Cycling Day on September 17th

This year we’ve support Finnish cancer research in co-operation with the Cancer Foundation Finland.

News | 02.09.2020

DRA takes part in the Nordic Regulatory Affairs seminar

The virtual event gathers Nordic authorities and actors within the pharmaceutical industry together to discuss current topics in their field.

News | 12.08.2020

Expert’s Voice – How to obtain over-the-counter status for a medicinal product Q&A

In this interview, our experienced marketing authorisation expert, will tell about the process and the questions that arise around it at application stage. 

News | 30.06.2020

Recruiting a MARKET ACCESS TEAM LEADER

We are looking for a MARKET ACCESS TEAM LEADER with a solid experience in strategic and operational market access in the Nordic countries.

News | 17.06.2020

It is a pleasure to introduce our new experts 

Over ten new experts have joined us.  Among them, both experienced top experts and new talents. 

News | 28.05.2020

DRA Consulting donates to University of Helsinki coronavirus research

By donating to research, we want to help solve this acute crisis and support our society to recover.

Blogs | 08.05.2020

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.

News | 07.04.2020

Our experts and team will help even in a state of emergency

We also want to help secure the operations of our customers.

Blogs | 03.04.2020

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.

News | 28.03.2020

Many new experts join DRA – our international expertise is increasing further

Welcome to join us Sari, Jonna, Stina and Jussi!

News | 17.03.2020

Information on the effects of Covid-19 on DRA’s business

Our team of experts is highly committed to support you during this difficult time as well as possible.

News | 01.03.2020

Patients have a voice – Five highlights from the Eupati Nordic Workshop

In future, patient involvement and the patients’ “voice” will have an increasingly important role.

News | 04.02.2020

Great results from our client satisfaction survey

We were particularly thanked for service-mindedness and meeting the agreed timelines as well as for co-operation fostering our clients’ business goals.

News | 10.01.2020

Returnee strengthens the DRA team

DRA has also been joined by a “returnee”, Eija Kinos.

News | 16.12.2019

DRA Consulting Oy wants to help fight the climate change

This year we made a donation to the Finnish Association for Nature Conservation in their climate protection work.

News | 12.11.2019

ISPOR Europe: More transborder co-operation between the authorities is needed in medicines evaluation and health technology assessment

Co-operation can produce high-quality and topical scientific reports, transparent processes and clear requirements for the evidence required.

Blogs | 01.11.2019

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.

News | 25.10.2019

Meet us at #ISPOREurope

Join us in Copenhagen on 2-6 November 2019! Drop by booth #C2-011 and have a chat with us.

News | 17.10.2019

TOPRA 2019: Technology poses challenges to the regulatory world – patient involvement is pursued

Is Europe prepared to assess medicines based on new technologies or novel innovations, or different types of study data?

News | 20.09.2019

TOPRA is approaching – See you there!

Meet us at the TOPRA Annual Symposium on 30 September – 2 October 2019 in Dublin, Ireland.

News | 15.08.2019

New EMA guidance on management of medicine shortages

EMA has published guidance to marketing authorisation holders and authorities to improve and harmonise management of medicine shortages and related reporting and communication.

Blogs | 24.07.2019

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.

News | 30.05.2019

Information about shortages does not reach prescribers – call for developers of communication voiced at the DRA expert event

The expert event brought together more than 50 representatives of the pharma industry and medicinal wholesalers to exchange experiences and thoughts on how to control availability of medicines.

News | 08.05.2019

Pauliina Lajunen appointed as Chief Operative Officer of DRA Consulting: “Towards new challenges via a genetic test”

Pauliina Lajunen will help boost DRA’s growth and internationalization with her business and marketing expertise. Welcome Pauliina!

Blogs | 06.05.2019

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.

News | 13.04.2019

Risk management materials and clinical work – do they meet?

Availability of risk management materials and electronic systems were much-discussed topics at the traditional pharmacovigilance seminar in Oslo.

News | 29.03.2019

Our team of great colleagues has grown again

Welcome, Suvi, Riina, Niko and Roosa!

News | 06.03.2019

More solid expertise to DRA

Our big team has grown even bigger! Welcome three new colleagues, Heidi, Heli and Tuomas!

News | 02.01.2019

Medicines verification is getting closer – checklist for pharma companies

Medicines verification to deter falsified medicines will be implemented as of 9 February 2019. Are you ready?

Blogs | 07.11.2018

Brexit is coming – is your product portfolio ready?

Many pharmaceutical companies have not yet submitted the necessary applications, and the deadline is already around the corner.

Blogs | 11.10.2018

Clear language saves time and money – also in the pharmaceutical industry

From the perspective of a person working in the pharmaceutical industry, the benefit/risk relationship of clear language is solely positive as benefits are numerous yet there are no adverse effects at all.

Blogs | 26.09.2018

Multilingual Nordic packages against availability problems

Multilingual Nordic packages are an important option for making medicines available in as many countries in the Nordic region as possible.

Blogs | 25.01.2018

A new digital era is dawning for PBB services

Last autumn, DRA was invited to participate in a pilot project concerned with real-life testing of the Pharmaceuticals Pricing Board’s electronic services.