Supporting Market Access to Essential Medicines in Europe

Challenge

Regulatory & compliance challenges

To bring their product to European patients, the company needed to secure an EU GMP license, conduct audits to demonstrate compliance, and establish a solid regulatory strategy.

In addition, they were responsible for compiling and submitting a complete dossier, managing communication with regulatory authorities, and implementing laboratory method transfer to support retesting and Qualified Person (QP) batch release.

Approach

QbD Group provided comprehensive regulatory and quality support to to guide the company toward market entry. Our approach included:

• Conducting audits at the API and finished product manufacturing sites to support the QP declaration.
• Developing a robust regulatory strategy, compiling the Common Technical Document (CTD) and eCTD for submission.
• Managing communication with regulatory authorities and addressing deficiency letters to streamline approval.
• Facilitating laboratory method transfer to ensure smooth retesting and QP batch release processes.

Result

Progressing toward market authorization

While the project is still ongoing, significant milestones have been achieved:

• Submission of key regulatory documentation to support the EU GMP licensing process.
• Active engagement with competent authorities to address regulatory feedback and refine submission materials.
• Future pharmacovigilance support planned to ensure ongoing compliance and patient safety.

The ultimate goal remains securing timely Market Authorization Approval enabling the company to introduce its product in Europe and expand patient access to essential treatments.