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

Regulatory Strategy: Guidance on nonclinical requirements for product development, clinical trials, and marketing applications. Support for FDA (INTERACT, Pre-IND, IND, NDA, BLA) and EMA (IMPD, IB, PIP, iPSP).

Document Preparation & Submissions: High-quality nonclinical submissions to global agencies (FDA, EMA, NMPA, TGA, Health Canada) with a proven track record of success.

Agency Representation: Prepare and attend regulatory meetings on your behalf to ensure clear communication and strategic alignment.

Global Compliance & Due Diligence: Advice on international regulations and gap assessments to reduce risk.

Integrated Development Support: Nonclinical input across all stages for seamless integration with clinical and regulatory plans.