Regulatory support for drugs

EU Legal Representation

• Official EU contact point for companies outside Europe, liaising with EMA and national authorities to ensure compliance

Medicinal Products – Regulatory Support

• Full-spectrum regulatory affairs: from R&D through lifecycle management for small molecules, biologics, biosimilars, ATMPs and vaccines

• CTD Module 1 support: tailored support for dossier prep in EMA, FDA and global regions

• Competent authority interactions: strategy, submission planning, scientific advice, pre-IND, pre‑CTA meetings

Quality/CMC, Non‑Clinical, Clinical Support

• End‑to‑end support across CMC, non‑clinical, and clinical phases, e.g. PIP/iPSP, first‑in‑human strategies, IND/IMPD prep

Orphan Drug, PRIME, Breakthrough Designations, accelerated approval pathways

• Identify best-fit designations (Orphan, PRIME, Breakthrough, Fast Track, RMAT, CAT etc.) and shepherd you through applications

Due Diligence & Gap Assessments

• Perform strategic regulatory gap analyses (e.g. MDR for devices, readiness assessments) to support M&A, funding, or internal compliance

Scientific Advice, Protocol Assistance, scientific advice Meetings

• Prepare and support EMA/FDA scientific advice requests and protocol reviews, smoothing the path from preclinical to clinical phases

MAA, NDA/ANDA (505(j) & 505(b)(2)), BLA, RoW Submissions

• Expert dossier preparation for MAA, NDA, ANDA, BLA, DMF; filings in EU central/decentralized procedures, US, Japan, Canada, TGA, TPD etc.

Clinical Trial Applications

• Guidance on IMPD, CTA, IND, including dossier writing, submission in eCTD/NeeS formats, and agency submission support