WELDING QU & RA – What we do for safety and quality

Regulatory Affairs - Our service for customers and suppliers

There is no such thing as complicated with us.

We comply with all regulatory requirements and are happy to assist our suppliers and customers. With our expertise we support, among others,


  • suppliers in the processing of CEP applications
  • suppliers in the creation and improvement of ASMFs
  • passing on information about planned changes (change notifications) from the supplier to the customer
  •  clients with a pre-assessment of the regulatory documentation.


As a further service, our customers can obtain pre-tested and revised regulatory documentation for APIs via WELDING. We offer suppliers support in the preparation and submission of registration documents – in this respect, we at WELDING act as an authorised representative to the EDQM for the CEP or to European national registration authorities for submission in the E-DMF procedure.

Our long-standing manufacturer contacts mean we are also very close to the so-called "transfer of information" – a clear time advantage for our customers: because we are notified directly and in detail of every change, no matter how small, made by the manufacturer. This allows us to work with our clients to implement the relevant change, whether it is a sample mailing, revised certificates or changed stock management, in a targeted and timely manner. Another advantage for our customers using our RA service is our excellent all-round knowledge of documents relevant to registration – we not only answer questions quickly, but above all competently and comprehensively.

We support API manufacturers with CEP applications and their revision. And we are also happy to help with the transfer of ASMF/CEP documents into the Electronic Common Technical Document - or eCTD format for short.


Welding contact

Quality by WELDING

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