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Compliance with the Falsified Medicines Directive

We can process map your supply chain to help you understand its complexity and ensure that action is taken to minimize any risks to your product as required under the Falsified Medicines Directive 2011/62/EU.

Our services include:

  • Select, evaluate, and define transportation routes and contingency plans
  • Selection, evaluation, auditing, and validation of transportation companies
  • Selection, evaluation, auditing, and validation of storage and distribution centers
  • Develop or improve your Quality & Technical Agreements with your suppliers and third parties; defining respective GxP responsibilities; and supporting effective vendor management as required by EU GMP Chapter 7 Outsourced Activities.
  • Evaluation of API and Finished Dosage Form transportation from manufacturer to end users
  • Marketing authorization compliance audits

 

Contact Us


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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