Boutique Life Sciences Advisory Services. Advanced Therapy Medicinal Product (ATMP) Focused.
Strong expertise in stem cells, gene therapy, CAR T-cell therapy, and advanced therapy medicinal products (ATMPs).
Our Team and our Expert networks are led by Dr. Janis Ancans.
His experience in the industry:
- served as a core member of the European Medicines Agency (EMA) Committee for Advanced Therapies Products and Cell Product Working Party;
- professional involvement in the classification and marketing authorization evaluation procedures;
- participation in the drafting process of related guidelines;
- external expert at The State Agency of Medicines.
This has been followed by professional experience with both public and private sector projects, including business consultations for the European Commission, Government bodies, KPMG, and Voisin Consulting.
Extended Advisory Service Team
Our network of experts covers former and existing executive senior-level employees of such regulatory bodies as the European Medicines Agency (EMA), FDA ATMP departments, and the Saudi FDA. We will invite people with the most suitable expertise to join your project, so you can be up to date with the latest regulatory requirements, and most innovative and cost-effective solutions out there.
PhD. Dr.biol. Janis Ancans
Who Are We Serving?
Government bodies seeking expert advice on setting guidelines and standards for the safe and effective use of CAR T-cell therapies.
Biotech companies in the early stages of CAR T-cell therapy development or looking to expand their portfolio into CAR T-cell therapies.
Hospitals and treatment centers looking to understand the logistics, quality management, and regulatory requirements for offering CAR T-cell therapies to patients.
Engaged in cutting-edge research and development of CAR T-cell therapies, needing guidance on commercialization and regulatory pathways.
New companies focused on CAR T-cell therapy looking for expertise in development, regulatory strategies, and market analysis.
Large pharma companies aiming to innovate or enhance their presence in the cell therapy space through CAR T-cell therapies.
Venture capital and private equity firms investing in biotech and pharma sectors, requiring due diligence and expert insights into the CAR T-cell therapy market.
Companies involved in the production and distribution of CAR T-cell therapies, needing to optimize processes and ensure compliance with quality standards.
Offering clinical trial services and looking for expertise in CAR T-cell therapy trials to better support their clients.
Our expert consultations have helped such public and private clients as:
Book an Expert Consultation
You can book a FREE 15-minute online phone consultation about your particular case with our Business Development consultant.