Regulatory Affairs Services Provider in France
France is one of Europe’s most regulated and strategically important life sciences markets, operating within the broader EU regulatory framework while maintaining distinct national requirements and authority interactions. Successful life sciences product registration in France requires in-depth knowledge of ANSM procedures, EU regulations, and France-specific compliance expectations.
At DDReg, we provide specialized Regulatory Affairs Services in France, supporting global and local pharmaceutical, biotechnology, and medical device companies with market entry, product registration, and full lifecycle regulatory compliance . With hands-on experience across French and EU regulatory submissions, DDReg serves as a trusted Regulatory Affairs Consultant in France, delivering structured, authority-ready regulatory solutions.
Understanding the Regulatory Affairs Process in France
Regulatory oversight in France is governed by the Agence nationale de sécurité du médicament et des produits de santé (ANSM), operating under the French Ministry of Health and in coordination with the European Medicines Agency (EMA) for EU-level procedures.
ANSM is responsible for:
- Authorization of pharmaceutical products via national, MRP, and DCP procedures
- Oversight of clinical trials and investigational medicinal products (IMPs)
- Medical device regulation under EU MDR (Regulation (EU) 2017/745)
- Supervision of GMP, GDP, and GCP compliance
- Post-market surveillance, vigilance, and safety reporting
As an experienced ANSM Regulatory Consultant, DDReg supports clients throughout the regulatory affairs process in France, ensuring submissions align with both EU regulations and France-specific authority expectations.
Our Regulatory Expertise in France
DDReg offers end-to-end regulatory consulting services in France, tailored for multinational and regional organizations. Our approach integrates local French regulatory intelligence with EU-wide regulatory strategy, enabling efficient approvals and sustainable market compliance. We work closely with ANSM and EU requirements to reduce approval timelines, manage regulatory risks, and support long-term product presence in the French market.
Our Regulatory Affairs Consulting Services in France
- Regulatory strategy and France market entry pathway assessment
- Product classification and EU–France regulatory compliance mapping
- Pre-submission regulatory planning and readiness assessments
- Preparation, publishing, and submission of dossiers (CTD / eCTD formats)
- National, DCP, MRP, and EMA-coordinated submission support
- Regulatory Services in France for pharmaceuticals and biologics
- Medical Device Registration in France under EU MDR
- Technical documentation, CER, and Essential Requirements compliance
- Labeling, IFU, and packaging review (French language requirements)
- Authorized local representative and local regulatory partner in France support
- Coordination and regulatory liaison with ANSM
- Gap analysis and regulatory remediation planning
- Lifecycle management, including renewals, variations, and post-approval changes
- Regulatory query handling and deficiency response management
- Post-market regulatory compliance, vigilance, and change control
- Ongoing local regulatory intelligence and monitoring of French regulatory updates
As a specialized France Regulatory Consulting Firm, DDReg ensures consistent, compliant, and authority-aligned regulatory execution.
Why Choose DDReg as Your Regulatory Affairs Consultant in France?
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ANSM-Focused Regulatory Expertise
Our consultants have deep knowledge of ANSM procedures, French authority expectations, and EU regulatory integration. -
Local Execution with EU & Global Perspective
We support France-specific regulatory requirements while maintaining alignment with EMA, ICH, and EU MDR frameworks. -
Strategic Local Regulatory Partner in France
DDReg is more than a regulatory service provider; we act as a local regulatory partner in France, supporting long-term compliance, lifecycle management, and regulatory risk mitigation.
Industries We Support in France
- Pharmaceutical and Generic Drug Manufacturers
- Biotechnology and Life Sciences Companies
- Medical Device and Diagnostics Manufacturers
- Combination Products and Advanced Therapies
- Companies entering or expanding in the French and EU markets
Our Regulatory Affairs Consulting Services in France portfolio covers:
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
