New Manufacturing and Import License Expands Batch Certification Services

June 2, 2021

ProPharma Group announced that its wholly-owned subsidiary ProPharma Group The Netherlands B.V., has obtained an authorization for a manufacturing and import (MIA) license. Following successful inspections by Dutch Inspectorate IGJ, ProPharma Group The Netherlands B.V. can now perform QP Batch Certification services under its own MIA license for pharmaceutical and biotech clients launching products to the European market (Schengen countries) and also release of existing products.

Eleonora Casucci, Vice President Life Science Consulting said, “We are very pleased to be a certified MIA license holder, in The Netherlands. This is of major importance for us as it not only adds greater flexibility to our batch certification services, but also signifies that we can offer greater value to our clients who wish to access the European market. We look forward to working with clients in leveraging these avenues.”

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 client need to obtain their 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.

 

About ProPharma Group

ProPharma Group is the global, independent, single-source provider of regulatory and compliance consulting, clinical research services, pharmacovigilance, and medical information serving pharmaceutical, biotechnology, and medical device companies. Founded in 2001, ProPharma Group has more than 1,900 colleagues worldwide providing a comprehensive portfolio of regulatory, clinical, and compliance solutions to help solve complex challenges in a dynamic regulatory environment. With the mission to improve the health and safety of patients, ProPharma Group is focused on delivering the highest quality of services throughout the full product lifecycle. For more information, please visit propharmagroup.com.




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