Reference is made to the recent notification issued by the European Medicines Agency on Friday, December 15th, recommending the suspension of more than 350generic medicines. The recommendation follows a Good Clinical Practice (GCP) inspection that uncovered irregularities in study data, inadequacies in study documentation, and deficiencies in computer systems and procedures for appropriately managing study data.
At Adalvo, we take immense pride in maintaining high-quality standards and ensuring the coordination of our dossiers and bioequivalence studies in accordance with the highest GCP standards. We are pleased to assure our esteemed partners that Adalvo has not been affected by this decision in any way.
Our quality team regularly audits all our actively used CROs including clinical facilities and processes, diligently ensuring that our partners conform to all applicable standards. This commitment reflects our dedication to providing pharmaceutical products of the utmost quality.
For detailed information on our product offerings, we encourage our partners to reach out to our Business Development team. We remain committed to delivering excellence in every aspect of our operations.
Reference data:https://ema.europa.eu/en/news/synapse-labs-pvt-ltd-ema-recommends-suspension-medicines-over-flawed-studies