Pharmaceutical quality

We document your quality

Benefit from our expertise: we assist you with the preparation of your pharmaceutical quality documents – from the documentation of individual aspects to complete quality dossiers.

Our services at a glance

Our portfolio encompasses:

• Quality of human medicinal products (CTD Module 3) and veterinary medicinal products (Part 2)
• Quality Overall Summaries (CTD Module 2.3) / Expert Reports
• Dossiers relating to the investigational product (IMPD) as an integral part of applications for the approval of clinical trials (human)
  
• European Drug Master Files (EDMF) / Active Substance Master Files (ASMF)
• Dossiers relating to applications for Certificates of Suitability (CEP) of the EDQM

Harness our experience to your product

Do your documents conform to the current formal, regulatory and scientific requirements? Our team of pharmacists, biologists, chemists, food chemists, and veterinarians will answer this question within the framework of a specific document management project – or independently thereof.

Good success prospects with the authorities

Our analyses, proposed solutions and the discussions with your in-house experts (if required) lay the foundations for the acceptance of your documents by the regulatory authorities.