Comprehensive Regulatory Solutions for Europe
Looking for expert regulatory solutions in Europe?
We offer comprehensive regulatory support for companies entering the European market, with a strong focus on Portugal and the UK.
Our services include Dossier preparation and submission, Regulatory fee payments, Certified translations, and Direct liaison with national regulatory authorities.
With deep expertise and local insight, we ensure a smooth, efficient, and fully compliant market entry.
Our Services
Europe Dossier Preparation & Submission
We specialize in the comprehensive preparation and submission of regulatory dossiers across various registration procedures, ensuring full compliance with European Medicines Agency (EMA) and National health authority requirements. Our experienced regulatory affairs team supports clients through every stage of the product lifecycle — from development through to post-marketing — with an emphasis on accuracy, efficiency, and strategic insight.
Mutual Recognition Procedure (MRP)
MRP allows a product already authorized in one EU member state (the Reference Member State, RMS) to be recognized by additional Concerned Member States (CMS).
Decentralized Procedure (DCP)
The DCP procedure allows an identical dossier to be submitted simultaneously in all selected Member States when no marketing authorisation has previously existed in the EU/EEA
Renewals and variations
We also support the submission of renewals and variations, ensuring timely updates and continued regulatory compliance for your EU-registered products.
Deficiency responses and Lifecycle Management
We are having expertise in preparing and submitting renewals, variations, and timely responses to deficiencies during different clock stops, ensuring uninterrupted progress of your regulatory procedures.
National Procedure (NP)
The National Procedure is used for obtaining marketing authorization in a single EU member state. Our team provides end-to-end support.
Marketing Authorization Holder (MAH) Services
In the European Union, obtaining marketing authorization requires strict compliance with EMA guidelines. Our MAH Service is designed to support companies in fulfilling these rigorous requirements. By partnering with local EU entities, we ensure that your facilities and operations meet all necessary regulations, facilitating clear communication with the EMA and Competent Authorities.
Supplementary Services for Europe
Expand your reach and streamline operations in the European market with our tailored supplementary services. From regulatory compliance to local customer support, we’ve designed each offering to help you navigate the complexities of Europe and accelerate your growth.
EU GMP Inspection Trigger
EU Local Agent Services
Market Authorization Holder (MAH)
Batch Release & Testing Support
QP (Qualified person) Support
Fees submission
Readability & Bridging
Labelling & Artwork
QPPV (Qualified person for Pharmacovigilance)
EU GMP SERVICES
We offer end-to-end EU GMP compliance solutions to help pharmaceutical and biotech companies to meet European regulatory standards. From new facility setup and system upgrades to audit preparation and documentation, our expert team ensures your operations are fully aligned with the latest EU GMP guidelines—efficiently, effectively, and inspection-ready.
Regulatory Authority Inspection Request : We support companies in requesting regulatory inspections from Portugal, Hungary, and the UK MHRA to facilitate market entry and GMP certification.
Comprehensive EU-GMP Compliance Verification: We assess your manufacturing processes, quality systems, and documentation to confirm alignment with EU regulations.
Inspection Readiness Support: From mock audits to gap analysis, we prepare your site for smooth and successful regulatory inspections.
GMP Declarations Assistance: We help draft, review, and manage GMP declarations to meet submission requirements accurately.
Coordination with Qualified Persons and EU Representatives: Seamless liaison with local QPs and EU Authorized Representatives ensures effective communication and compliance management throughout your product lifecycle.
Partner with us to strengthen your GMP compliance framework and confidently navigate regulatory inspections across Europe.
