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Manufacturing and Import License (MIA) and European Market Access

Accelerate Product Launch and Market Access with Qualified Person (QP) Certification

Navigating both the specific country and general European regulations and requirements to gain access to European markets can be a complex challenge. On top of the varying requirements, Sponsors looking to enter the European markets must create tailored market access strategies per country and establish a legal entity with a QP in the region. All of which can be extremely difficult for even the most experienced individuals.

ProPharma Group can perform QP Batch Certification services under its own MIA license for pharmaceutical and biotech clients launching products to the European market (Schengen countries), as well as release for export from the European market (eg, to the United States) and release of existing products.

Immediate Market Access with ProPharma Group’s MIA License

Partnering with the leading industry compliance experts will help unravel these complexities to improve business efficiency, shorten timelines, and reduce overall costs. This will allow you to further focus on product development, clinical studies, and commercialization to support patient access and safety.

The company’s MIA license allows ProPharma Group to help clients overcome the complexities of accessing the EU markets, like navigating country and EU regulations, creating tailored strategies per country, and lifts the Sponsor’s need to obtain its own MIA license with a QP in the region. All of which helps ensure products are released to patients in need across the EU in a quick and flexible way.

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Your Business has Complex Challenges. ProPharma Group has Exceptional Solutions.

We partner with pharmaceutical, biotechnology, and medical device clients to tackle complex challenges. Contact us to learn how our experienced team can help ensure regulatory and development success throughout the product lifecycle.

Interested in gaining an industry edge? Let us help you stay up to date.


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