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