Regulatory services

Pharmaceuticals and Medical devices

Regulatory service - on you terms and conditions

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.

Regulatory affairs

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

Quality assurance (QA) is about assuring and monitoring product quality during manufacture and after the product has been released on the market.

Pharmacovigilance (PV)

Drug safety (PV) includes the collection, detection, assessment, monitoring and prevention of adverse effects in pharmaceutical products.

Compliance

Compliance with regulations, ethical rules and voluntary limits (company policies, procedures, etc.) for promotional material, contacts with patient organisations and healthcare professionals.

Medical devices

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.

Work areas

Regulatory affairs

Services:
Marketing licences
Clinical trials
Life-cycle management
Product information
Artwork
Product launch
Market Intelligence

Quality assurance

Services include:
Claims processing
Quality management system
Process description
(Processes and instructions)

Pharmacovigilance (PV)

Services include:
Medical information
Adverse effects reporting
Literature monitoring

Compliance

Services include:
Review of promotional material
Review of information material
Support and sounding board for company compliance

Medical devices

Services include:
Technical documentation
Post Market Surveillance (PMS)
Claims processing
Product information
Artwork

Regulatory services

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.