End-to-end quality and regulatory solutions in training, consulting, validation and auditing.
Founded in 2015, BerKal Akademi provides professional consulting, auditing, training and quality system solutions to companies in the human and veterinary pharmaceutical industry, as well as cosmetics, biotechnology, API (active pharmaceutical ingredients), excipients, medical devices and food supplements.
Our scope also includes cGxP (GMP, GDP, GLP, GCP, etc.) focused quality and regulatory consulting for machinery/equipment manufacturers, system providers, logistics companies and other suppliers serving the industry. Processes for hospital stem cell and advanced therapy units are also among our areas of activity.
Our approach is not just about preparing documents; it is about building quality systems that work on the shop floor, are sustainable and are ready for inspection.
Risk management based on scientific data and current regulations.
Systems aligned with EU GMP, EXCiPACT and global standards.
CSV, data integrity and electronic system integration.
A holistic approach from training to validation, from auditing to consulting.
EudraLex Vol.4 — European quality requirements for the manufacture of medicinal products for human use.
GxP Framework — global GMP & GDP certification for excipient manufacturing.
Quality Management System — the international general QMS standard.
Data Integrity — the core principles of modern GMP inspections.
By combining regulatory knowledge, field experience and an auditor's perspective, we offer companies not just consulting but quality system solutions that actually work.
No copy-paste: we design quality system solutions that fit each company's operational reality and work in practice.
We internalise the inspector's perspective when preparing for EU GMP, EXCiPACT and industry inspections, building systems around the reality of an audit.
We manage validation, qualification and technical operations together with quality processes, developing an integrated system mindset.
We evaluate global quality requirements alongside digitalisation, CSV and modern quality technologies to deliver future-ready solutions.
We work on a project basis or as full-time consultants depending on your needs, simplifying processes rather than adding to your workload.
Not a one-off intervention: we work as a sustainable, long-term partner that helps your company embed a culture of quality.
At BerKal Akademi, our core quality principle is to deliver sustainable solutions that meet customer expectations, comply with legal requirements and stay open to technological developments.
We aim for the systems we build to meet not only today's needs but also tomorrow's.
Our decisions are shaped by scientific data, current regulations, technical expertise and risk management principles.
We see quality not as paperwork but as a data-driven, traceable and sustainable way of managing.
We closely follow technology, digital transformation and global quality trends and integrate them into processes.
We regard data reliability, traceability and transparent process management as the cornerstones of quality systems.
Not theoretical: we develop systems that work on the shop floor, are sustainable and hold up during inspections.
We evaluate global quality requirements together with digitalisation and modern quality technologies to offer integrated solutions.
We carry out all our activities with independence, confidentiality, professional ethics and a sense of responsibility.
We believe training, knowledge sharing and quality awareness are the foundation of sustainable growth.
Quality systems that meet global standards and actually work.
Our mission at BerKal Akademi is to help companies build sustainable, practical quality systems that comply with global quality standards and current regulations, and to deliver solutions that add real value to operations through technical expertise, an auditor's perspective and a digital approach to quality.
A preferred brand nationally and internationally.
To be a preferred auditing, training and consulting brand at national and international level, recognised for reliable, innovative and sustainable solutions across all quality system areas, GxP first and foremost.
Let's analyse your current situation together and plan the road to your goals.