Achieving full compliance with EU regulatory standards is increasingly demanding.
Pharmaceutical companies must meet stringent requirements to access and operate in the European market. Without proper guidance, the risk of regulatory setbacks, delayed qp release, or failed inspections is significant.
If companies don’t address compliance from the start, they may encounter:
These challenges not only affect your time-to-market but also your company’s credibility with regulators and partners alike.
Our team combines decades of pharmaceutical regulatory experience with a sharp focus on delivery. We work alongside your internal team to:
With Billev Pharma East, your compliance strategy is in expert hands – supported by our experienced gmp consultants and eu qualified person specialists.
Billev farmacija vzhod, d. o. o.
Billev Pharma East Ltd.
Tržaška cesta 202
1000 Ljubljana
Slovenia
In the European Union, the release of medicinal products to the market is strictly regulated under Directive 2001/83/EC and EudraLex Volume 4 – requiring that each batch be certified by a qualified person eu.
Compliance with these obligations is not only a legal requirement but a quality assurance standard that safeguards patient safety and product integrity.
In preparation for any gmp audit, the eu qp must ensure that all manufacturing operations are in full compliance with EU GMP and that documentation is accurate, current, and auditable. Audit readiness is a critical part of QP oversight responsibilities and reflects the strength of the company’s quality system.
The role of the eu qualified person includes review and approval of manufacturing documentation, evaluation of batch records, oversight of deviation management, and confirmation that the product complies with the Marketing Authorisation and GMP guidelines.
At Billev Pharma East, we provide strategic QP support tailored to your product type (biologicals, ATMPs, small molecules) and development phase – from clinical to commercial. Our gmp consultants ensure that your manufacturing and quality systems are fully aligned with EU regulatory expectations.
A robust Pharmaceutical Quality System (PQS), aligned with ICH Q10 and EU GMP Annex 16, is essential for maintaining consistent product quality and regulatory compliance. Within this framework, the eu qualified person plays a central role in ensuring that manufacturing operations meet current expectations.
The QP must have access to comprehensive quality data and documentation, including Product Quality Reviews (PQRs), deviation reports, and analytical results, before certifying any batch for qp release. This integrated approach strengthens traceability, ensures product conformity, and facilitates a state of continual improvement across the supply chain.
We support clients through every phase of gmp consultation, providing guidance, oversight, and operational support via a qualified gmp consultant or eu qp as needed.
October 2025 – Frankfurt (Germany):
Our team representatives Katja Pečjak Reven and Maša Voler attended CPHI Frankfurt 2025, held 28-30 October, to engage with industry-leaders, explore emerging pharmaceutical trends and reinforce our commitment to European market partnerships. Read more
April 2025 – Wiesbaden (Germany): At the GMP PharmaCongress & GMP PharmaTechnica Expo 2025 held April 8-9, our colleague Špela Perčič participated and shared key insights into Good Manufacturing Practice (GMP) trends, digitalisation and regulatory developments. Read more
QP batch certification for release of the medicinal products to the market.
Support with procedures aimed at obtaining GMP certification.
Regulatory support during on-site HA inspections.
Release of the medicinal products for clinical (IMP) and bioequivalence (BE) studies in accordance with GxP.
GMP audit of API manufacturers and finished product manufacturers.
Consultations on QMS system for GMP.
Training of personnel.
With a focus on expert guidance and strategic insights, we propel your projects forward with confidence, ensuring every step is handled with precision.
Regulatory Affairs
Pharmacovigilance
Medical Consultancy
Quality/GxP
Digital Consultancy
