Case Study – Oncology Client

Oncology Client

A client came to us seeking oncology marketing authorisations for as many EU countries as possible. Over a two-year period, we concluded deals for 9 molecules and after running additional registrations the client had MA’s in 11 member states. IPG ran all the regulatory procedures, quality management and supply chain.

What We Did

In parallel, the client was constructing a new facility and IPG were engaged to oversee the engineering validation, quality compliance by locating team members in the facility for 3 weeks a month for two years. We successfully obtained EU GMP approval on first inspection with short corrective action plan – from a brown field through technical transfer to first tender supply in just over 4 years.

Results We Achieved

ICE Pharma Group (IPG) is a generic pharmaceutical company

9

We concluded deals for 9 molecules.

11

At conclusion, the client had MA’s in 11 member states.

  1. What were the challenges?

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If you are have a quality management or compliance project you need assistance with, get in touch with us to discuss your requirements and learn more about how we can help.