Regulatory Affairs & Compliance
From strategy to approval. We navigate the complex landscape of health regulations (EMA, AEMPS, FDA) to transform regulatory hurdles into competitive advantages and accelerate your market entry.
SERVICES (Feature List)
Strategic Consulting:
Development of regulatory roadmaps, Gap Analysis, and preparation for Scientific Advice meetings with authorities.
Dossier Management:
Preparation, publishing, and submission of registration dossiers in eCTD format for medicines and medical devices.
Lifecycle Management:
Comprehensive management of variations, renewals, and notifications to keep your commercial licenses active and compliant.
Medical Devices (MDR/IVDR):
Expert support for CE marking and transition to the new European regulations for medical devices.
Pharmacovigilance:
Set up safety systems, draft periodic reports, and risk management plans.
DIFFERENTIATION (Global Reach)
Global Reach, Local Expertise. Whether you are a European company expanding into Latin America and China, or an international firm entering the EU market, we act as your official link. We understand the local nuances that prevent costly delays in evaluation.
Do you need to unblock a procedure or plan a registration?
Clinical Biotec S.L. – Spanish Tax ID (CIF): B56379233
Based in Madrid, Spain.
Registered in the Mercantile Registry of Madrid. We act as commercial representatives and authorized distributors for national and international companies in the technological, editorial, scientific, and academic sectors.
Email: santiago@clinicalbiotec.com
Copyright © 2023–2026 Clinical Biotec. All rights reserved.