Regulatory Consulting Services | EMA & FDA Submission Support
Failure to align early with regulatory expectations can cause costly delays or derail product development. You will want to design compliant development strategies, prepare high-quality submissions, and engage confidently with regulatory authorities. We can design pathways for pharmaceutical products, medical devices, and cognitive tech.
Services
Regulatory Strategy Development: Gap analysis, global pathway mapping, phase‑appropriate CMC & clinical plans.
Submission Authoring & eCTD Publishing: IND, CTA, NDA, BLA, 510(k), MDR Technical File—written, formatted, and validated.
Agency Meeting Coaching: Briefing books, Q‑list rehearsals, on‑call support during FDA Type B, EMA Scientific Advice, HC meetings.
Risk & Compliance Audits: Early‑stage dossier review, GxP and CMC red‑flag detection.
Need Some Help?
Contact us for any inquiries or to book a free 30‑minute consultancy call.
