Our mission is to provide an effective and efficient interaction between companies and regulatory Authorities from development to registration of new drugs. We are delivering outstanding services and solutions through dedication and excellence because satisfying our customers with the appropriate level of quality is our primary goal and the fundamental element of our mission.

You can benefit from our
  • Long-term experience in pharmaceutical industry
  • Highly professional expertise in the planning and preparation of regulatory documents
  • Customer focused approach
  • Open communication
  • Flexibility, creativity and integrity
  • Capability to provide assistance at all stages of product development
  • Confidentiality and adherence to professional standards of excellence

We are committed to supporting you make substantial performance improvement. We assist you during all regulatory activities required from the development to the approval of your drug product and afterwards. With every customer we build dynamic multidisciplinary teams to thoroughly match individual applications to the constantly evolving regulatory demands.


Phone +49 (0) 7251/305 529
Fax +49 (0) 7251/305 528


  • 29.08.2019
    Frankfurt: Prozessvalidierung - Aktuelle Anforderungen für CMC
  • 17.-18.09.2019
    Copenhagen: Drug Master File Procedures in the EU, the US and Japan
  • 27.09.2019
    Frankfurt: Regulatorische Anforderungen an Primärpackmittel
Get all events


  • 10.03.2017
    News for the Industry
  • 26.07.2013
    News on Change Control/Variations:
  • 31.01.2013
    EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
Get all news
EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.
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