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;
  • Support on target identification and validation;
  • Selection of relevant animal models based on disease indication and target antigen expression;
  • Determination of maximum tolerated dose (MTD), no observed adverse effect level (NOAEL), and safety margins for human dosing extrapolation;
  • Assess tissue penetration, accumulation, and elimination pathways;
  • Compilation of preclinical data for regulatory submissions, including Investigational New Drug (IND) applications;
  • Preparation of preclinical study reports, study protocols, and regulatory dossiers in compliance with regulatory guidelines (e.g., ICH, FDA, EMA);
  • Engagement with regulatory agencies for pre-IND meetings, protocol reviews, and submission discussions;
  • Documentation to support regulatory marketing approval of a monoclonal antibody (mAb) – Therapeutic Biologics Application (BLA).