Billev Pharma East Ltd.

Billev Pharma East is a Slovenia-based consultancy dedicated to support pharmaceutical companies; manufacturing human or veterinary medicines, and medical devices companies bring safe, effective products to market efficiently. Drawing on decades of regulatory, quality, and inspection experience at both industry and authority levels, the company guides clients through EU and international requirements from early development to post-market.

Billev’s integrated model unites services in regulatory affairs, pharmacovigilance, quality and GxP, including GMP consulting and batch release, medical writing, ISO 13485 consulting with medical devices expertise, and digital transformation.

With one point of contact and a single dedicated team, partners gain cohesive collaboration, faster approvals, and a seamless path from development to launch.

Vision & Mission

Under its founding vision of “One Partner. Comprehensive Solutions,” Billev’s mission is to provide an end-to-end partner that integrates every key function – for both human and veterinary medicinal products – across regulatory, pharmacovigilance, quality, medical and clinical.

By delivering these capabilities under one roof, Billev helps partners accelerate speed to market, strengthen compliance, enhance efficiency, and align strategy – ensuring cohesive collaboration, faster approvals, and seamless progress from development to launch.

This approach opens an all-in-one gateway to EU and other markets, meeting every challenge from navigating regulatory hurdles and safeguarding patient safety to ensuring total quality management and digitalizing workflows.

Activities & Services

Billev Pharma East’s portfolio covers all the functions needed to develop products and bring them to market, including:

• Regulatory Affairs (EU/UK & International): Strategy, gap analyses, scientific advice, dossier writing, including publishing (eCTD/VNeeS), submissions, authoring product information,  lifecycle management.
• Pharmacovigilance (GVP and VGVP): PV system setup and maintenance, QPPV services, PSMF creation and maintenance, signal management, case processing, RMPs, PSUR/PBRER, GVP audits.
• Quality & Compliance: GMP/GDP/GCP/GVP alignment, implementation of quality management system and maintenance, training (including GMP training for employees, training on data integrity, good documentation practice as well as GDP, GVP), vendor qualification, internal and supplier audits, inspection readiness and hosting.
• Medical & Clinical Support: Medical writing services for regulatory or clinical study documentation, toxicology assessments, clinical study or bioequivalence design, and pre-clinical development.
• GMP Batch Release (EU): EU/UK QP release of imported batches with Qualified Person (QP) oversight and supply chain integration.
• Digital Transformation: Implementation of electronic product information, Validation of computorised systems, data integrity, workflow digitalization.
• Medical Devices (ISO 13485/MDR/IVDR): MDR and IVDR gap analysis, QMS implementation, medical device technical file, Vigilance, PRRC, Authorised representative, MDR Article 117 guidance, notified body liaison, ISO 13485 audits and suppliers qualification.

Quality, Regulatory & Standards

At Billev Pharma East, quality is embedded in every consultancy and operational process. While not a manufacturer, the company applies the same rigorous principles expected in regulated pharmaceutical and life-science environments.

Recognized for Quality Excellence:

• MIA & GMP certificate: batch release & importation
• GMP & GDP qualified auditor
• ISO 13485 certified
• MD-QMS ISO 13485:2016 Lead Auditor
• GCP Certified Auditor
• ISO 9001:2015 certified

Structure & Background

Founded in 2007 in Slovenia, Billev Pharma East Ltd. was established to provide specialized consultancy services for the pharmaceutical and medical device industry, combining deep regulatory and inspection heritage with pragmatic, industry-tested solutions.

The company’s initial focus on regulatory affairs consultancy for medicinal products soon expanded to include pharmacovigilance, medical writing, quality assurance and GMP batch release services.

Billev’s leadership has been strengthened by authority-level inspection expertise and participation in European regulatory institutions, enabling the company to serve a broad client base across EU Member States and selected third countries through an experienced consultant network and international partners.

The company expanded and grew stronger under the visionary leadership and strategic directions of Dr. Sebastjan Reven. He has more than two decades experience in pharmaceutical technology, quality assurance, and regulatory oversight as a former Head of the Pharmaceutical Inspection Division at the Slovenian competent authority and participant in several European regulatory bodies.

Headquartered in the Slovenian capital Ljubljana and operating as an independent consultancy, Billev primarily serves European countries while also supporting clients in international markets.