FEATURED NEWS
QP Declarations – Key Considerations
So are you preparing and filing a Marketing Authorisation Application (MAA) in Europe? What needs to be considered and what timelines
Welcome to the Team
We would like to welcome Ciara Kearney, Lisa Evans, Sherry A Calimlim and Olivia McEvoy to the MIAS Pharma Team. They are
Good Practices for Data Management and Integrity
The pharmaceutical industry is underpinned by a large amount of documentation to show evidence of the quality, safety and efficacy of
QP Declarations – Key Considerations
So are you preparing and filing a Marketing Authorisation Application (MAA) in Europe? What needs to be considered and what timelines
MHRA (GxP) Inspections during COVID19
The COVID19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. MHRA understands the impact of its work
Good Practices for Data Management and Integrity
The pharmaceutical industry is underpinned by a large amount of documentation to show evidence of the quality,
QP Declarations – Key Considerations
So are you preparing and filing a Marketing Authorisation Application (MAA) in Europe? What needs to be
Top 5 considerations when getting a Manufacturer’s/Importation Authorisation (MIA)
A Manufacturer’s/Importation Authorisation (MIA) is required if a company is involved in manufacturing and/or importation activities relating to
Regulations for Pharmaceuticals Post Brexit
The European Commission has published a Communication to prepare for the end of the transition period. The document is appropriately entitled "Getting ready for changes
Complying with new GDP requirements
In an ever changing and complex industry the role of the Responsible Person has developed and grown over the past 10 years as
QP Responsibilities
MIAS Pharma provides QP services for commercial and investigational medicinal products. Our QPs have experience in oversight and release of multiple types of