Medimo Oy
Services
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.
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.
Other services
• Strategic regulatory planning
• Project management
• Consulting (e.g. product classifications, scientific advice, national requirements)
• Training
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!
