consultation about all topics related to the CMC field

The HWI team works according to all currently valid regulatory requirements for human medicinal products, veterinary medicinal products as well as borderline medical devices and medical devices with ancillary drug substances.

We support you in all analytical questions and relating regulatory questions:

  • Setting and reviewing of specifications, analytical procedures and validations reports based on current scientific state-of-the-art and regulatory requirements
  • Planning and conducting method transfers
  • Gap analyses of CTD modules 2.3/3 together with our experts from regulatory affairs, product development and production

Contact:
Christiane Wiegand
, Head of Laboratory Services
Email: c.wiegand(at)hwi-group.de
Phone: +49 7272 7767-2521

Dr. Melanie Kerst, Managing Director
Email: m.kerst(at)hwi-group.de
Phone: +49 7272 7767-2510

Beratugn CMC klein
 

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