Preparing an MAA or NDA?
Rigorous writing, a clear narrative, and a thorough understanding of regulatory expectations are the pillars of a strong dossier.
At Asphalion, we have supported 140+ MAAs and 40+ NDA-related projects, helping clients navigate the complexity of regulatory strategy and full dossier writing, including Module 1 (including ERA M1.6 and RMP), Module 2 scientific summaries, clinical and non-clinical overviews, and CMC documentation—delivered with scientific rigour and strategic clarity, and tailored to each product type and submission pathway.
Our experience spans:
Product types: Biologics, biosimilars, small molecules, NCEs/NMEs, ATMPs, fixed-dose combinations, and hybrid products
Therapeutic areas: Oncology, dermatology, immunology, rheumatology, neurology, and more
Regulatory pathways and geographies: EMA Centralised Procedures, EU Decentralised Procedures, national MAAs, FDA NDAs, other international agencies, and a wide range of regulatory pathways
Behind every successful submission is a team that understands not only science, but also strategy. Our Scientific and Medical Writing team adapts each dossier to its specific context: indication, product type, regulatory agency, and timeline.
Because bringing a product to market starts with getting the documentation right.
Working on an upcoming submission? Let’s talk! Contact us at: [email protected]
