- Home
- >
- All Countries
- >
- European Union
360-degree Regulatory solutions in the European Union
Holistic product lifecycle management from inception to product launch and post-marketing surveillance, Artixio offers complete solutions.
European
The European Union (EU) is a sophisticated and harmonized regulatory market globally. The EU represents 27 member states as a single market for diverse industries, including pharmaceuticals, medical devices, biologics, cosmetics, and food products, that are underpinned by stringent regulations and a regulatory framework. The EU regulatory services market has seen significant growth in the past decade, with increasing innovative products across the life science industries. According to a latest industry survey, the European outsourcing market for regulatory services is estimated to have reached USD 3.5–4.0 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 7–9% by 2030.
Over the decades, Artixio has leveraged its deep expertise in the industry to successfully introduce the product into the market by adhering to the legal framework in the European Union.
Regulatory Bodies in the European Union
The European Medicine Agency (EMA) is a centralised authority responsible for overseeing the quality and safety aspects of all life science products. A decentralised system under EMA, comprising a National Competent Authority (NCA) within each member state, governs regulations concerning medical devices and regulates the legal framework for the import of life science products.
Key Authorities:
- European Commission (EC) – Grants centralized marketing authorizations and implements legislative directives and regulations.
- Notified Bodies (NBs) – Conformity assessment entities responsible for certifying medical devices under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
- European Directorate for the Quality of Medicines (EDQM) – Oversees quality standards across the EU.
Pre-Registration
- Regulatory Intelligence & Strategy designed for EMA framework
- Product / Market Prioritization based on EU market
- Dossier Gap Analysis
- Technical Due Diligence
- EU Market Access Strategy
Registration
- EMA Product Registration and Legal Representation
- Dossier Preparation as per EMA standards
- Medical / Technical Writing Labeling and Artwork
- EMA Review Preparation
- Health Authority Meetings and Liaison
- EMA Audit Support
- eCTD/CTD Publishing and Submission
- Response to Queries / Approvals
- Compliance Analysis and Assessment
- QMS, Mock Audits & Vendor Audits
- Pricing & Reimbursement
Post-Registration
- Product Lifecycle Maintenance
- Artwork / Label / Ad-promo Reviews as per EMA guidelines
- Line Extensions
- Response to EMA Regulatory / Safety Queries Distribution / Import Assistance
- EMA Compliance monitoring
- Post-marketing Surveillance
- Product Recall & Change Management
- Advertisement & Promotional Material Review
Our Services
Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
Why Us?
Integrated service covering the complete product lifecycle
Expertise in the EU regulatory framework with 15-35 years of experience
Flexible Business Model to suit the client's requirements
AI-driven, regulatory services supported by QuriousRI
ISO 9001:2015 regulatory services
Customer-centric, flexible services and solutions.
Industries We Serve in the European Union
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
FAQs
What are the key components of a regulatory submission dossier in the EU?
EU submission follows a standard Common Technical Document format including: Regional Administrative Information (EU-specific), Overview and summaries, Quality (CMC), Non-clinical study reports and Clinical study reports
What support does the EMA provide for small and medium-sized enterprises (SMEs)?
The EMA extends support with incentives such as fee reductions or waivers, regulatory guidance, and scientific guidance to SMEs based in the EU.
When should a company use the decentralized procedure?
Decentralized Procedure (DCP) is applicable when a product has not yet been authorized in any EU country and the applicant wishes to obtain authorization in several EU countries simultaneously.
When should a company use the mutual recognition procedure?
Mutual Recognition Procedure (MRP) is applicable when a product has already been authorized in one EU country and the applicant wants to extend it to other EU member states.
Our Global Reach: Serving Life
Sciences Clients Worldwide
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
Europe
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
Insights from Artixio - Tips & Articles
Pharma Manufacturing Booms in
Hildalgo had good pharmaceutical infrastructure and supply chain capabilities, but with no foreign investment...
UK Releases Amendment &
In January 2025, MHRA UK released guidance on implementation of amendments to Medical Devices...
Artixio Announces Grant for
HYDERABAD, India - March 27, 2024 - Artixio, a leading compliance and commercial consulting...