Mission

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.

HOTLINE

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

Events

  • 25.08.2020
    Online Seminar: Prozessvalidierung - Aktuelle Anforderungen an CMC-Daten
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  • 06.-07.10.2020
    Vienna: Change Control – New Aspects and Best Practices
    More
  • 08.-09.10.2020
    Vienna: ICH Q8 – Q11 Training Course
    More
Get all events



News

  • 18.05.2020
    Impact of COVID-19 pandemic on Pharma: GMP and Regulatory Flexibility
    More
  • 26.03.2020
    New Deadline for Nitrosamine Impurities
    More
  • 24.03.2020
    News on Nitrosamine Impurities
    More
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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