EMA certification for a drug can only be obtained for a product, not for the company.

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EMA readiness

You produce your pharmaceuticals outside the EU? But you want to offer them in the EU area? We help you become EMA ready. The EMA, the European Medicines Agency, is mandated to promote scientific excellence in the evaluation and supervision of medicines for the benefit of human and animal health in the European Union (EU). To fulfill its mission, the European Medicines Agency (EMA) works closely with national competent authorities in a regulatory network.

Your advantages

  • The INOSOLVE experts know the requirements of the EMA.
  • You will be accompanied and guided through the process by INOSOLVE experts.
  • You save resources and achieve your goal.
  • INOSOLVE has an excellent network to potential European partners.

Our services

  • The INOSOLVE experts identify your GAPs by means of GAP Assessment, define necessary optimizations and accompany you on your way to EMA certification.
  • INOSOLVE experts prepare you for authority audits.
  • INOSOLVE is looking for the right partners for cooperation in the European area
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