Certificate of Suitability (CEP) Services:

Efficient CEP Management:

ERA streamlines the process of obtaining CEPs for excipients and other substances used in pharmaceutical products. Our experts will handle the submission and communication with the European Directorate for the Quality of Medicines (EDQM) to secure CEPs efficiently.

Regulatory Compliance:

We ensure that your CEP submissions meet EDQM’s stringent quality and safety standards.

Our rigorous quality control processes and attention to detail result in successful CEP approvals.

Global Reach:

While we focus on EDQM submissions, we also offer guidance on the broader implications of CEPs, including their acceptance in various international regulatory authorities.

ERA helps you leverage CEPs to simplify your global regulatory strategies.

If you would like any further information on how we can help you with any aspect of a CEP please contact us.