A UK based company with manufacturing locations around the globe and a large consumer healthcare portfolio required in-market compliance check for its products all across the globe. The brands were very popular and could not afford to go off the shelf due to non-compliance should an agency inspection happen.
DDReg was tasked to carry out the regulatory gap analysis and remediation of the gaps. Considering the enormity of the project a big dedicated team of experts was formed by DDReg. The team tirelessly worked over 2 years using dedicated systems and processes, maintaining full data confidentiality.
As a result team was able to deliver assessments on about 1300 licenses, thereby helping the customer organization get their in-market products in compliance to country/regional regulatory requirements.
Exploring the Evolving Regulatory Landscape for Gene Therapy Trials in the EU