Pharmaceutical development /
Regulatory services

We have more than 30 years of experience in the development and regulatory affairs of drug formulations. We will be happy to support you and consult on all matters relating to this field.

Our services in detail

  • >Development of parenteral formulations (incl. manufacture and testing of laboratory samples)
  • >Development of liquid formulations for topical or oral application (incl. manufacture and testing of laboratory samples)
  • >Development of capsule formulations (incl. manufacture and testing of laboratory samples)
  • >Selection and testing of primary containers (incl. testing of container suitability and compatibility)
  • >Preparation of reports on formulation and process development as well as process and cleaning validation relating to manufacture of the drug product
  • >Development and manufacture of liposome formulations on a laboratory scale
  • >Preparation of Drug Master Files (ASMF/DMF, CTD, quality overall summaries etc.)
  • >Dealing with deficiency letters regarding APIs and drug products
  • >Support for all regulatory filings and agency interactions

MAXIMATOR® HPE

Device for the manufacture of liposomes by means of filter extrusion on a laboratory scale

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