Regulatory Affairs Services Provider in Poland
Poland is one of Central and Eastern Europe’s most important life sciences markets, offering strong growth potential within the European Union regulatory framework. However, successful life sciences product registration in Poland requires a clear understanding of national authority requirements, EU regulations, and local administrative practices.
At DDReg, we provide specialized Regulatory Affairs Services in Poland, 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 Polish and EU regulatory procedures, DDReg serves as a trusted Regulatory Affairs Consultant in Poland, delivering compliant, authority-ready regulatory solutions.
Understanding the Regulatory Affairs Process in Poland
Regulatory oversight in Poland is managed by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), operating under the Polish Ministry of Health and in coordination with the European Medicines Agency (EMA).
URPL is responsible for:
- Authorization of medicinal products via national, MRP, and DCP procedures
- Oversight of clinical trials and investigational medicinal products
- Regulation of medical devices under EU MDR (Regulation (EU) 2017/745)
- Supervision of GMP, GDP, and GCP compliance
- Pharmacovigilance, materiovigilance, and post-market surveillance
As an experienced Poland Regulatory Consultant, DDReg supports clients throughout the regulatory affairs process in Poland, ensuring submissions align with both EU requirements and Poland-specific authority expectations.
Our Regulatory Expertise in Poland
DDReg offers end-to-end regulatory consulting services in Poland, tailored to multinational and regional organizations. Our approach integrates local Polish regulatory intelligence with EU-wide regulatory strategy, enabling efficient approvals and long-term compliance. We work closely with URPL and EU regulatory frameworks to reduce approval timelines, manage regulatory queries, and support sustained market presence in Poland.
Our Regulatory Affairs Consulting Services in Poland
- Regulatory strategy and Poland market entry pathway assessment
- Product classification and Poland–EU regulatory compliance mapping
- Pre-submission regulatory planning and readiness assessments
- Preparation, publishing, and submission of dossiers (CTD / eCTD formats)
- Pharmaceutical regulatory affairs in Poland
- Drug regulatory consulting in Poland for new drugs, generics, and variations
- National, DCP, MRP, and EMA-coordinated submission support
- Regulatory services for medical devices in Poland under EU MDR
- Technical documentation, CER, and Annex II & III compliance
- Labeling, IFU, and packaging review (Polish language requirements)
- Authorized local representative and regulatory representation support
- Coordination and regulatory liaison with URPL
- 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 Polish regulatory updates
As a dedicated Poland Regulatory Consulting Firm, DDReg ensures consistent, compliant, and authority-aligned regulatory execution.
Why Choose DDReg as Your Regulatory Affairs Consultant in Poland?
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Poland-Focused Regulatory Expertise
Our consultants possess deep knowledge of URPL procedures, national administrative requirements, and EU regulatory integration. -
Local Execution with EU & Global Perspective
We support Poland-specific regulatory needs while maintaining alignment with EMA, ICH, and EU MDR frameworks. -
Strategic Partner for Market Access
DDReg goes beyond submissions, supporting long-term compliance, lifecycle management, and regulatory risk mitigation in the Polish market.
Industries We Support in Poland
- 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 Polish and EU markets
Our Regulatory Affairs Consulting Services in Poland 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...
