• Regulatory Compliance: Registration with local authorities, handling inspections, and monitoring regulatory updates.

• Local Safety Oversight: Provision of LPPV/LQPPV and deputy roles with 24/7 availability where required.

• PV System Management: Development and maintenance of local SOPs, manuals, and PSMF.

• Case Handling: Collection, follow-up, and submission of ICSRs in line with local requirements.

• Literature & Intelligence: Screening local medical literature and translating minimum criteria.

• Risk Minimization & Medical Info: Implementing educational materials and managing inquiries in local languages.

• Training & Coordination: Staff training, regular meetings with EU QPPV, and activity tracking.

• Product Complaints & Recalls: Local support for complaint and recall processes.

• We cover several EU markets: Czechia, Slovakia, Romania, Germany and Austria

• Virtual or on-site workshops

• Duration: 2–3 days (customizable)

• Materials: Training slides, case studies, and practical exercises

• Audience: Regulatory Affairs team, QA/Compliance staff, and related functions

• Regulatory Compliance Framework: Development and implementation of processes aligned with EU and international regulatory requirements.

• SOP Creation & Maintenance: Drafting, reviewing, and updating Standard Operating Procedures for Regulatory Affairs and related functions.

• Local Adaptation of Global Policies: Translating and customizing global SOPs to meet country-specific requirements.

• Process Optimization: Designing workflows and internal guidelines to improve efficiency and ensure audit readiness.

• Training on SOPs & Compliance: Conducting staff training sessions on new or updated SOPs and compliance standards.

• Audit Preparation & Support: Ensuring documentation and processes meet inspection and audit requirements.

• Regulatory Intelligence and Strategy Development of filings for CP, DCP/MRP, NP procedures; preparation of new applications and life-cycle management submissions.

• Project Management & Coordination: End-to-end management of global and EU regulatory projects, including timelines, translations, and cross-functional communication.

• Global & EU Regulatory Expertise: eCTD/NeeS publishing, compliance with EU and international guidelines.

• Post-Authorisation Activities: Variations classification and submission, renewals, extensions, PSURs, labeling, and artwork management.

• CMC Support: Module 3 compilation, baseline submissions and dossier due diligence for chemistry, manufacturing, and controls.

• Clinical Trial Support: Filing clinical trial registrations on CTIS and ensuring compliance with Clinical Trials Regulation.​

• RA support on local level in most EU countries with Regulatory Affairs SMEs based in Czechia, Slovakia, Romania, Germany and Austria.

• Review of promotional materials for HCPs conferences, materials intended for general public promotion, etc.

• Support in organizing HCP events in EU countries

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