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Consulting Services

Biotech and pharmaceutical companies often tend to outsource distinct activities to contract manufacturing organizations or contract laboratories due to absent or limited resources and/or for economical reasons. A focus often lies with all activities associated to GMP.

Thus, GMP consulting offered by Pharmedartis builds the foundation for the development of the production process and the analytical procedures as well as to the etablishment of the quality system comprehending the production, quality control, quality assurance, and batch release.

But not only GMP consulting is a domain offered by Pharmedartis. A related area pertains to the technical regulatory activities for Active Pharmaceutical Ingredients (APIs). The support for the Chemistry, Manufacturing, and Controls (CMC) part needed for IND or NDA submission is also a service provided by Pharmedartis.
Specific technical consulting is offered regarding sophisticated technologies for sterile manufacturing and inactivation and removal of viruses or prions.

A non-technical consulting area by Pharmedartis supports the customer in market analysis and commercialization of possible new molecular entities.

As a summary Pharmedartis consulting services pertain to the following  distinct arenas: 

  • regulatory  intelligence and support (e.g. for preparation of CMC)
  • manufacturing technology (incl. sterile technology)
  • viral safety
  • support in market analysis and commercialization
  • GMP consulting (please read GMP operations)