Regulatory Affairs

The process of developing a product all the way to its approval is time-consuming, places enormous demands on the manufacturer and must proceed successfully. 

To carry out good manufacturing practice (GxP) in concordance with respective regulatory requirements, it is necessary to conduct precise and efficient monitoring and maintenance of the documents.   

Quality Pharma Projects has many years’ experience in the area of regulatory affairs.  We have the scientific know-how to evaluate authorisation dossiers (medicinal products) and technical documentation (medical devices) and help pharmaceutical firms to adhere to respective regulatory requirements.  Our extensive knowledge of formal guidelines is the basis of dealing safely with the challenges such rules bring up, and enable us to demonstrate the chances and synergy effects which are extremely valuable for the marketability within the life cycle of a medicinal product or medical device. 

Quality Pharma Projects assists with other products besides EU and non-EU pharmaceutical approvals as well.  We will also gladly advise you on issues such as conformity assessment or CE labelling for medical devices.