WELDING PHARMA FDF – what we do for you

Regulatory Affairs

Precision and overview are required in all activities to obtain and maintain approvals.

From the compilation of documents and dossiers in eCTD format, to the preparation of marketing authorisation applications and electronic submission of marketing authorisations as well as the management of procedures and the processing of regulatory assessment reports, our team clarifies all enquiries and requirements of the regulatory authorities with the partner.

This also includes maintaining and updating approvals or carrying out change and variation procedures.


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Pharmaceutical Know - How by WELDING

Contact us with your queries and we can suggest potential solutions.