The path from the first substance sample to the clinical sample is often a long one – with more than one official hurdle having to be overcome. To ensure that these regulatory affairs do not develop into pitfalls for the project, good advance planning and a view of the whole are essential in project planning. Having an experienced partner by your side who not only has the necessary know-how but can also support you in carrying out this work is certainly advantageous in this.

HAPILA GmbH offers you advice tailored to your needs on the way from the research model to the clinical model and through to the submission of the documents for the market launch and market supply. During our 15 years of experience in the active ingredient sector, we have accompanied several established companies and start-ups on the way from the product idea to official approval of the active ingredient in the international market area.

We have our GxP-compliant quality continuously checked and certified by independent authorities.

Have you founded a start-up or do you want to take your API to the clinical phase as quickly as possible? Then take a look at our extensive service package. We will be happy to advise you.

  • preparation of the necessary regulatory documents (synthesis & analytics)
  • qualification and validation
  • GxP compliance consulting
  • pre-compliance tests (test audit and audit preparation)
  • development of product specifications (for starting materials as well as intermediate products and APIs)
  • synthesis development (scale up: laboratory scale, clinical sample, market supply)
  • synthesis of reference standards (metabolites and impurities)
  • market supply up to the multi-100 kg/a scale (GMP manufacturing)

You still have questions? Then contact us!

Contact Person: Dr Uwe Müller