Consult formal and regulatory affairs environment in Poland Regulatory Affairs & Compliance for Medicinal Products and Food Supplements in the EU Our regulatory affairs specialists and quality assurance experts provide end-to-end consulting services for companies planning to launch pharmaceutical products, food supplements, and FSMP in Poland and the EU. Pharmaceutical Products We support registration and compliance of: Prescription Medicines (Rx) Over-the-Counter Drugs (OTC) Generic Drugs Biological Products and Biosimilars Active Pharmaceutical Ingredients (APIs) Veterinary Medicinal Products Our expertise covers EMA and national procedures (DCP, MRP, national, centralized), pharmacovigilance systems (QPPV), and GMP compliance. We prepare: eCTD / NeeS Dossiers Module 1 for Poland and EU markets Risk Management Plans (RMP) Summary of Product Characteristics (SmPC) Patient Leaflets & Labelling Compliance We ensure compliance with EU pharmaceutical law, including: Directive 2001/83/EC – Medicinal Products for Human Use Regulation (EU) 536/2014 – Clinical Trials Veterinary Medicines Regulation (EU) 2019/6 Food Products & Nutrition We provide regulatory strategy and registration support for: Dietary Supplements Food for Special Medical Purposes (FSMP) Novel Foods Functional Foods Fortified Foods Infant Formula & Clinical Nutrition Our services include: Composition and Ingredient Assessment (EFSA compliance) Labelling and Health Claims Review (Regulation (EC) 1924/2006) Additives and Contaminants Check Notification Procedures in Poland and other EU countries HACCP and ISO 22000 implementation We ensure compliance with EU food law, including: Regulation (EC) 178/2002 – General Food Law Regulation (EU) 1169/2011 – Food Information to Consumers Regulation (EU) 609/2013 – Foods for Specific Groups Medical Devices & Borderline Products For companies introducing medical devices or borderline products (drug-device combinations, cosmetics with health claims), we: Prepare Technical Documentation in compliance with MDR 2017/745 Support CE Marking Process Advise on product classification and claims Why Choose Us? Experts in Polish and EU regulations Support from regulatory strategy to market entry Representation before Polish authorities: Chief Pharmaceutical Inspectorate (GIF) Chief Sanitary Inspectorate (GIS) Veterinary Inspectorate Experience in GMP, GDP, ISO 9001, ISO 22000, ISO 13485, HACCP We reduce legal risks, ensure regulatory compliance, and accelerate time to market for your medicinal products, food supplements, FSMP, veterinary medicines, and cosmetics in Poland and the EU. Local Regulatory & Pharmacovigilance Support in Poland Vestango provides comprehensive regulatory and PV support for local and EU procedures, ensuring full compliance throughout the product lifecycle. Our services cover both human and veterinary medicinal products, including generics, and support clients from dossier preparation to post-approval maintenance. Key areas of support include: Preparation and submission of national modules (Module 1) for Poland, including all administrative and legal documentation. Coordination with the Office for Registration of Medicinal Products (URPL) during the national phase, including management of queries, deficiency letters, and timeline monitoring. Lifecycle management: handling of variations, renewals, labelling updates, and dossier maintenance. Local adaptation of SmPC, PIL, and labelling, including QRD compliance and readability assessment. Regulatory intelligence and monitoring of local requirements, procedural updates, and safety communications. MAH Quality & PV System Establishment We assist Marketing Authorization Holders (MAHs) in establishing robust QMS and pharmacovigilance systems, fully aligned with EU and national regulations: Development of SOPs covering PV processes, regulatory lifecycle management, quality oversight, GDP responsibilities, and artwork/labelling governance. Preparation of PSMF summaries and system structures compliant with EU and VICH guidelines. Support for inspection readiness of MAH systems, including URPL audits. Technical Due Diligence & CMO Oversight Vestango ensures that all contracted manufacturers (CMOs) meet EU GMP standards and dossier readiness requirements: Evaluation of CMO quality systems, analytical validation, and production capabilities. Gap analysis against EU and Polish requirements for medicinal products and veterinary products. Coordination of responsibilities between MAH and CMO for PV, batch release, labelling, and dossier ownership. Post-Authorisation Support Our team can provide ongoing post-approval services, including: Full PV outsourcing (Local Contact Person, ICSR management, signal detection and management, PSUR submissions). Handling of variations, renewals, and labelling updates. Regulatory compliance oversight and support during inspections and audits. Management of quality and medical complaints, ensuring MAH compliance at all times.
