MIAS Pharma2022-07-26T21:26:17+00:00

MIAS SERVICES

Our Services Cover Diverse Product Markets.

EU QP Declarations

MIAS assists companies with their MAA application by providing a QP Declaration to substantiate their submission. As MIAS holds MIA Licences we are often named both as Site of Batch Release and for Product Defects and Recalls.

QP Audits

In Europe no batch of medicinal product can be released for sale or supply prior to
certification by a Qualified Person (QP) who is named on an MIA (Manufacturer’s/
Importation Authorisation).

EU QP Batch Release

In Europe no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP). For a QP to certify a batch of a drug product the QP is required to be named on a licence known as an MIA (Manufacturer’s/ Importation Authorisation).

Virtual Quality Assurance

Working with our client’s Quality, Operations, Supply Chain and Regulatory teams to map the physical and financial ownership flow of materials and products in your supply chain, we identify all 3rd parties involved; we evaluate their licence status; we determine if their Quality standards are adequate and we support maintenance of those Quality standards to support QP services. We provide all QP services from API declarations to routine batch disposition

Supply Chain Oversight

Pharmaceutical supply chains often extend across multiple transportation routes and regulatory jurisdictions. Without Supply Chain Oversight these complex supply chains present challenges in terms of maintaining quality of medicinal product in-transit and the increasing global risk of Falsified Medicines entering the supply chain.

Supply Chain Mapping

MIAS facilitates experts on EU Law and Taxation to work with our client to define the ideal EU Entity structure from a legal and financial perspective to maximise tax benefits and R&D rebates in Europe for current and future product lines.

OUR MISSION

“To accelerate the availability of medicines to patients within the EU.”

MIAS Pharma provides a licensing framework to enable pharmaceutical importation and batch certification.

OUR VISION

Supply chain oversight partner.

To be the supply chain oversight partner of choice for International Pharma /Biopharma companies for product release into Europe. 

MIAS INSIGHT

Latest Market & MIAS Updates.

BREXIT – Impact, Challenges and Solutions for the Pharmaceutical Industry

August 9th, 2022|Categories: Events, Featured, General Events|

Our CEO Ann McGee will be speaking at the Pharma and Brexit Conference - hosted by PDA Ireland and PDA United Kingdom. The event will

The Commenting Process for new GDP-relevant Documents from FDA and USP has been extended.

July 27th, 2022|Categories: Featured, General News, Industry News|

FDA Proposed Rule "National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers" In February 2022, the FDA has

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