Exellerium AB is a Sweden-based regulatory consultancy specializing in global regulatory affairs for biotech, pharmaceutical, and medtech companies.

We help accelerate the development and approval of innovative new medicines and medical devices — including cell and gene therapies (ATMPs), biologics, new molecular entities (NMEs), small molecules, and combination products.

Our Services
• Global Regulatory Strategy – Definition and implementation of regulatory pathways across the product lifecycle, from preclinical development to marketing authorization.

• Regulatory Agency Interactions – Preparation and support for meetings with regulatory authorities (e.g., FDA Pre-IND/Pre-IDE, End-of-Phase, Pre-Submission meetings, EMA or national Scientific Advice).

• Regulatory Documentation Review – Scientific and regulatory review of key documents such as Clinical Study Protocols (CSP), Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Investigator’s Brochures (IB), Preclinical Reports, and Risk Management Files (RMF).

• Regulatory Submissions – Leadership and authorship of submissions such as IND/CTA (Clinical Trial Application), PSP/PIP (Pediatric Study/Investigation Plans), ATMP Classification and Certification, BLA/NDA/PMA (Biologics License, New Drug, and Premarket Approval applications).

• Expedited Designations – Preparation of applications for Orphan Drug; RMAT, Breakthrough Therapy, Fast Track (U.S.) and PRIME (EU) designations to accelerate development.

• Representation Services – Acting as US Agent and EU Agent to ensure continuous communication with regulatory authorities.

• eCTD Publishing & Submission – Preparation, publishing, and electronic submission of regulatory dossiers in eCTD format.

Since 2024, Exellerium has also been investing in early-stage life science startups, providing strategic guidance, regulatory expertise, and financial backing.

Exellerium

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Exellerium

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