Safety first

Responsible business practice supported by an efficient and transparent Quality Management has been our standard policy for a long time.

In addition, many of the standards we have been practicing have meanwhile become legal requirements and are thus compulsory for everyone. We at Welding think that this is a positive development. Among these standards are supplier qualification, including audits at manufacturing sites, as well as pharma­ceu­tical release of products for which we have an import licence.

Of course you can expect more from us:
We are importers into the EU and distributors of pharmaceutical products, for which an Import- and Manufacturing Licence is required according to the German medicinal law (AMG). In order to obtain and keep such licences, we are regularly inspected by the Health Authority. It is a prerequisite for receiving the licence that the company works in accordance with EU GMP guidelines (ICH Q7) and its translation into German law by the AMWHV.

Our customers can therefore be assured that:

  • we have a GMP-compliant Quality Management System
  • we have a Qualified Person and a Head of Manufacturing
  • we only buy from qualified suppliers, not only for those products for which we have an import licence
  • we ensure full transfer of information. This includes management and transfer of all documents which are required for regulatory reasons
  • we conduct GSP conforming storage of goods

In addition we offer product development of generic APIs and finished drugs. For APIs we identify suitable sources and cooperate closely with these sources in order to obtain marketability for regulated markets for these APIs. Our services include:

  • GMP-consulting and audits
  • IP-consulting
  • Support for compilation of ASMFs and CEPs

For finished drugs we develop generic formulations with suitable partners. Our services include:

  • Selection of suitable APIs and suitable API-sources (see above)
  • technical support for questions regarding formulation
  • compilation of the registration dossier, submission of the dossier, management of the registration procedure