Advanced Therapies

Advanced Therapy Medicinal Products (ATMPs) represent a class of pioneering therapeutic interventions that use advanced technologies and techniques to treat, modify, or regenerate human tissues and cells. This category encompasses gene therapies, cell therapies, tissue-engineered products, and combined advanced therapies, each designed to address diseases at the molecular and cellular levels.

Our consultants have 25+ years of  experience both in small and large molecules. We can provide strategic direction from early drug discovery to first in human.

In particular, for advanced therapies, we have experience and provide the following services:

  • Classification of Advanced therapy medicinal products (ATMPs);
  • Evaluating and performing gap analyses on data packages to meet EMA requirements for both Clinical Trial Application (CTA) and Marketing Authorisation Application (MAA);
  • Assessing the capacity to participate in early access programs and obtain orphan drug designations (ODD);
  • Providing strategic guidance on development plans for ATMPs.

 In our work with ATMPs we efficacely apply a number of guidelines, such as:

According to the nature of the product, guidelines for the development of a conventional DS/PD may be also applied.