Regulatory Affairs Services Provider in European Union
The European Union has one of the most structured and quality-driven regulatory frameworks in the world. As an experienced Regulatory Affairs Consulting Partner in the EU, DDReg supports pharmaceutical, biotechnology, medical device, nutraceutical, cosmetic, and food supplement companies in achieving successful and compliant EU approvals.
Whether you are working toward your first CE Marking, EMA marketing authorisation, or managing lifecycle submissions across EU-27 markets, DDReg provides the scientific, regulatory, and operational expertise needed to ensure compliance, accelerate approvals, and maintain post-market obligations.
Understanding the EU Regulatory Landscape
The European Union follows a harmonised regulatory environment led by key authorities, including:
- European Medicines Agency (EMA)
- Heads of Medicines Agencies (HMA)
- National Competent Authorities (NCAs) across EU member states
- Notified Bodies for CE marking of medical devices
Core EU Regulatory Affairs Services Responsibilities Include:
- Review and approval of human medicines, biologicals, biosimilars, ATMPs, and medical devices
- GMP, GDP, and GCP compliance oversight
- Market authorisation review via Centralised, Decentralised (DCP), Mutual Recognition (MRP), or National procedures
- Pharmacovigilance and safety monitoring through EudraVigilance
- Compliance with EU Labeling, Serialization (FMD), and lifecycle modifications
With evolving frameworks including EU CTR, IVDR/MDR regulatory shifts, and ongoing digitalisation through eCTD 4.0, regulatory navigation in the EU requires specialised expertise and proactive adaptation.
EU Regulatory Affairs Services by DDReg
- Marketing Authorisation Application (MAA) support
- EU submission pathway strategy (Centralised, DCP, MRP, National)
- eCTD publishing and submission management
- Quality, nonclinical & clinical dossier development
- Gap analysis & regulatory readiness assessments
- Pharmacovigilance system setup & QPPV support
- Medical device CE marking under MDR/IVDR
- Labeling, artwork, and EU serialization compliance (FMD)
- Lifecycle management (variations, renewals & line extensions)
- Regulatory intelligence and EU policy monitoring
Why Choose DDReg for Regulatory Affairs in the EU?
- EU regulatory pathway expertise across biologics, advanced therapies, generics, medical devices, and combination products
- End-to-end regulatory support from scientific advice to post-approval compliance, ensuring continuity and lifecycle traceability
- eCTD-driven digital capability, including eCTD 4.0 transition, EMA Gateway uploads, and compliant document authoring
- Local knowledge with a global perspective aligned with EMA guidelines, ICH standards, and NCA requirements
