Comprehensive Regulatory Solutions for Europe
Looking for expert regulatory solutions in Europe?
We offer comprehensive regulatory support for companies entering the European market.
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
Our Regulatory Dossier Services cover the complete lifecycle of submission documentation—from initial compilation and submission to ongoing maintenance. We ensure dossiers are accurate, compliant, and aligned with regulatory requirements and quality standards, supporting efficient approvals and seamless lifecycle management.
Our services include:
Regulatory Dossier & Market Authorization Solutions
RGInsight delivers comprehensive dossier and market authorization support, from initial development and submission through regulatory review and lifecycle management.
European MAH & Product Release Support
Support for Marketing Authorization Holding, batch importation, testing, and product release requirements in Europe.
New Product Registration & MAA Support
End-to-end preparation and compilation of Modules 1–5 for new Marketing Authorization Applications.
Generic, Hybrid & Bibliographic Applications
Preparation of regulatory dossiers for generic, hybrid, and bibliographic medicinal products.
Dossier Assessment & Regulatory Gap Analysis
Expert evaluation of existing dossiers to identify regulatory, technical, and documentation gaps before submission or expansion.
Regulatory Authority Response Management
Preparation of scientifically sound and comprehensive responses to questions and deficiency letters from regulatory authorities.
Regulatory Module Development & Updates
Preparation, revision, and maintenance of individual dossier modules to address evolving regulatory requirements and new data.
Multi-Market Dossier Adaptation
Strategic adaptation of regulatory dossiers to meet the specific requirements of different countries and regulatory authorities.
CTD/eCTD Dossier Compilation & Publishing
Professional compilation, structuring, and formatting of dossiers in accordance with ICH CTD/eCTD standards.
Submission Readiness & Quality Compliance Review
Detailed quality and compliance assessment to ensure dossiers are complete, consistent, accurate, and submission-ready.
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.