Pharmacovigilance and quality services for medicines and medical devices with expertise

We ease your burden and help in the best way so that the products meet the regulatory requirements and are safe to use. For example, you can outsource to us all the pharmacovigilance tasks or the batch release for medicinal products.

Six reasons to choose Medimo as a service provider

Long experience

Medimo has an extensive experience of managing the lifecycle process of the medicinal products.

Knowledge and skill

You will get answers to your questions. We will tell you clearly how things are or should be.

Nordic know-how

We know the local legislation, especially in the Nordic countries.

Speed and agility

As a small organization, we can react to changes quickly. Internal decision-making is simple and fast. Everyone has responsibility for their own projects.

Outsourcing many tasks

Medimo stays and keeps itself up to date with the requirements of the pharmaceutical industry – you can outsource to us safety, quality and marketing authorizations tasks.

We can develop your processes

We are not satisfied with just managing the processes, we can develop them more fluent, if needed.

Anu Gummerus, Founder of Medimo Oy.

Our best expertise are pharmacovigilance and quality tasks for human and veterinary drugs and medical devices. We know how to roll up our sleeves and go to business. A small and agile company can take on tasks even on a fast schedule. We may provide a solution to the question that has been puzzling your mind, because we have been working in the field for a long time.

Anu Gummerus, Founder of Medimo Oy.

Pharmacovigilance and quality services with expertise

We provide you with a reliable and competent worker who knows how to be a part of a team

The Founder of Medimo, Anu Gummerus, has more than 20 years of experience in working with tasks related to marketing authorisations, pharmacovigilance, and quality of medicinal products. According to Anu’s motto, “the work is done well, right at once, but not as hairsplitter”.

Years of experience in the entire life cycle of the marketing authorisation process of medicinal products and especially knowledge of the local requirements in the Nordic countries guarantee the handling of pharmacovigilance and quality services with professionalism.

Examples of work requests


  • EU QPPV tasks of the pharmacovigilance system
  • Release of medicinal batches to the market by QP
  • Global and local literature monitoring (Nordic countries)
  • Quality Responsible Person / Accountable director (or assistant or deputy)
  • GMP and GDP audits
  • Audits of the pharmacovigilance system
  • Promotional, marketing and educational material review
  • Preparing or updating product information texts for medicines
  • Compilation of marketing authorisation applications and variations

Our services

for pharmaceutical companies and companies working on medical devices

Pharmacovigilance

Pharmacovigilance activities are regulated by GVP (Good Pharmacovigilance Practices) and therefore also within the scope of regulatory inspections. That is why it is important that pharmacovigilance system is in order and up to date so that the safety of the medicine can be guaranteed throughout its life cycle.

Quality services

We offer consulting services related to quality management and quality processes. We have expertise in pharmaceutical wholesale (GDP) and pharmaceutical good manufacturing practices (GMP) quality assurance.

Auditing

From us you can get auditing services for the pharmacovigilance system. By auditing the pharmacovigilance system, you ensure that patient safety is taken care of as required by law.

Promotional, marketing and educational material review

You can leave the promotional, marketing and educational material review to us. Reviewing marketing materials requires accuracy and knowledge of legislation and guidelines. With our help, you can receive up to date educational and marketing materials in a timely manner.

Marketing authorisation applications

We manage all marketing authorisation services for human and veterinary drugs for you: we compile applications, maintain marketing authorisations, write product information texts, update national regulatory databases, and offer translation assistance.

Outsourcing

Sometimes there can be a situation that you need a worker inside your own company. In such cases, passing on information, sharing and participating in meetings may be more interactive and serve your company better.

Medimo offers everything needed both to get new drugs onto the market and to manage the life cycle of old drugs. It does not matter where you work – contact us!

Medimo in numbers

years of experience

works remotely in four different locations

cross-country skiing kilometres for the whole team

rowing kilometres for the whole team

books read per year

Your target, our solution, one goal

Contact us and we will discuss how we can help your company.