Contract, Research, and Development

Here you can learn more about our services in the field of contract development and research for pharmaceuticals, dietary supplements, and medical devices.

The Aenova Group is one of the leading global contract development and manufacturing organizations for the pharmaceutical and healthcare industries. The abbreviation CDMO (Contract Development and Manufacturing Organization) is commonly used in the industry. Thanks to our dedicated research and development (R&D) headquarters in Muttenz, Switzerland and an additional seven production sites with R&D departments, Aenova is also represented globally in the field of research and development. The modern development and production facilities are (c)GMP certified and comply with the certification standards of international health authorities, including the American FDA and ANVISA, and thus guarantee a high level of quality and efficiency throughout all the stages of product development and manufacture.

Our services in the field of contract development and manufacture at a glance:

  • We offer our customers tailor-made solutions through specialist R&D teams and effective project management for development projects.
  • We develop and validate analytical methods to support raw material testing, drug product characterization, and ICH stability testing1.
  • We support the entire product development process including the development of formulation concepts, the manufacturing and packaging of clinical trial material, the coordination and organization of clinical studies, and the full compilation of certification dossiers.

Full Pharmaceutical Development 

  • Complete development of dossiers on behalf of customers
  • Formulation concepts & process development
  • Analysis of raw materials, intermediates, finished products, and stability studies
  • Scale-up studies2
  • Manufacturing and packaging of clinical trial material
  • Management of BE studies3
  • Product transfers

Full Nutraceutical Development

  • Development of new products and product concepts
  • Innovative technologies
  • Galenical and analytical development
  • Stability testing
  • Product transfers

Full Medical Device Development

  • Development of new products and product concepts
  • Innovative technologies
  • Expert regulatory advice on marketability and customer benefit
  • Support for legal strategic options and issues of delimitation
  • Expert assistance for galenical forms and manufacture
  • Advice for labeling medical devices

 

 

Learn more about R&D at Aenova.

1 ICH = International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (www.ich.org).
2 "Scale-up" refers to the scaling up of the production process practiced in chemical or biochemical process development. The aim is to construct a technical production plant.
3 BE (bio-equivalence) = evaluation of the interchangeability of two drugs with the same active ingredient that are differentiated in the manufacturing process and/or by the excipients they contain.