Regulatory service - adapted to your needs
Medhouse have extensive experience of providing business support to services in the regulatory field. We are highly experienced and possess comprehensive knowledge of current regulations and legislation on pharmaceuticals and medical devices in the Nordic countries.The extent of the project can be a few hours or more extensive.
A specialist area that monitors how pharmaceuticals and medical products are developed, tested, manufactured, marketed and distributed so that the requirements in guidelines and regulatory frameworks are met.
Quality assurance (QA) is about assuring and monitoring product quality during manufacture and after the product has been released on the market.
Drug safety (PV) includes the collection, detection, assessment, monitoring and prevention of adverse effects in pharmaceutical products.
Compliance with regulations, ethical rules and voluntary limits (company policies, procedures, etc.) for promotional material, contacts with patient organisations and healthcare professionals.
Are products and technologies used to treat, care, diagnose and improve or maintain health. This can include advanced equipment in hospitals or self-care products.
Quality management system
Processes and instructions
Adverse effects reporting
Review of promotional material
Review of information material
Support and sounding board for company compliance
Post Market Surveillance (PMS)
We have extensive experience and a deep knowledge of current regulations and legislation for pharmaceuticals and medical devices in the Nordic region. You determine the scope of the project. It can be a few hours or a more comprehensive project.