​​​

• Markets covered: Czech Republic | Slovakia | Romania | Austria

• LQPPV (Local Qualified Person for Pharmacovigilance) services

• PV system setup and maintenance

• SOP development and QMS support

• Regulatory authority liaison (SÚKL, ŠÚKL, ANMDM, BASG)

• Signal monitoring and safety reporting

• Audit preparation and CAPA management

• Training and compliance reviews

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

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

• Screening of local medical literature 

​​​​​​

• Markets covered: Czech Republic | Slovakia | Poland | Romania

• National market entry strategy

• Regulatory submissions and variation management

• Authority correspondence and follow-up

• Labelling and SmPC review

• Review and preparation of educational materials and additional risk minimisation measures (aRMMs)

• Promotional materials review

• Liaison with national competent authorities

• Regulatory Strategy & Submissions: New marketing authorisation applications and lifecycle management across CP, DCP/MRP, and national procedures.

• Project Management: End-to-end management of EU and global regulatory projects — milestones, timelines, and cross-functional coordination.

• eCTD Publishing: eCTD and NeeS publishing in compliance with EU and ICH submission standards.

• Post-Authorisation Activities: Variations, renewals, PSURs, labelling, and artwork management.

• CMC Support: Module 3 authoring, baseline submissions and due diligence.

• Clinical Trials: CTIS registration and compliance with EU Clinical Trials Regulation (CTR 536/2014).

• Regulatory Compliance: Building processes that meet EU pharmaceutical legislation and national CZ/SK/RO/PL regulatory requirements.

• SOP Management: Creating, updating, and maintaining SOPs to ensure compliance with EU and local laws.

• Local Policy Adaptation: Adjusting global SOPs to align with CZ/SK/RO/PL legislation and local Health authorities expectations.

• Process Efficiency: Designing clear workflows that support compliance and keep documentation audit‑ready.

• Training: Providing practical training on SOP updates, EU guidances, and CZ/SK/RO/PL compliance needs.

• Audit Support: Preparing teams and documentation for SÚKL/ŠÚKL/NAMMDR/UPRL inspections and internal audits.