We will take care of it.
Are you looking for a reliable partner for global regulatory affairs? We will be happy to help. More information here


Reliable marketing authorisation in compliance with global standards

Thanks to its intensive involvement with our own products and those of our partners, our bene Regulatory Affairs department has years of experience in professionally conducting marketing authorisation procedures in direct contact with regulatory authorities worldwide.

Our services for your company:

  • Regulatory support ranging from development projects to the lifecycle management of medicinal products for human use and medical devices
  • Generation of chemical and pharmaceutical documentation meeting the highest scientific standards
  • We enable electronic submissions via modern submission management systems following country-specific formats, e.g. eCTD in Europe.
  • All regulatory activities conducted in accordance with current law and the latest guidelines.
  • For our products and quality data, we always guarantee regulatory compliance.

We will be happy to support your individual marketing authorisation project from development to market launch.