Pharma & Biotech Engineering
Pharma & Biotech Engineering: GMP Validation, ATEX Compliance, and Reliable Production Solutions
With over a decade of multidisciplinary expertise, Optivion Engineering delivers end-to-end support for highly regulated environments. Our work covers the full lifecycle: drafting URS documents, leading technical and economic evaluations, executing FAT and SAT, and completing IQ/OQ/PQ protocols. By ensuring GMP compliance and flawless technical execution, we enable faster time-to-market, safer production environments, and sustainable growth for pharma and biotech manufacturers.
We specialize in designing, validating, and optimizing pharmaceutical and biotech manufacturing processes — from Lecigon gel filling lines to ATEX-compliant equipment installations and GMP qualification (URS, FAT, SAT, IQ, OQ, PQ).
One of the key challenges in pharma and biotech projects is the transfer of technology between different production lines or facilities. Optivion Engineering provides end-to-end support for technology transfer, ensuring that processes developed on one line are seamlessly adapted to another with different equipment, scale, or regulatory requirements.
- ✅URS & Vendor Engagement Development of clear User Requirement Specifications (URS), preparation of RFQ/RFP packages, and execution of techno-economic vendor evaluations. Focus on Total Cost of Ownership (TCO) and selecting the optimal supplier aligned with GMP and ATEX requirements.
- ✅FAT / SAT Supervision of Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) procedures. Verification of critical acceptance criteria, testing of data integrity (DI) functionalities, and integration with MES/SCADA systems for full compliance and operational reliability.
- ✅Compliance Assurance Ensuring compliance with international standards and regulations: EU GMP Annex 1, 21 CFR Part 11, ATEX 2014/34/EU, and ISO 14644. Strong focus on contamination control, electronic records, and process safety.
- ✅Deliverables Delivery of complete audit-ready documentation, user and maintenance training sessions, and a handover package fully prepared for inspections and regulatory audits.
- ✅Technology Transfer & Process Adaptation Managing the transfer of pharmaceutical and biotech processes between different production lines or facilities. Activities include adaptation of process parameters, updating SOPs, and executing risk assessments to secure product quality. Full coordination with equipment vendors and client teams ensures smooth scale-up, minimized downtime, and complete GMP compliance.
Solution
At Optivion Engineering, our solutions extend far beyond the simple delivery of equipment — we provide full lifecycle support, covering everything from URS development and supplier negotiations to GMP validation and production start-up. Each project is guided by a structured framework that blends technical expertise, regulatory compliance, and economic analysis, ensuring safe, efficient, and cost-effective implementation. By integrating ATEX and GMP standards with proven engineering know-how, we deliver pharmaceutical and biotech solutions that not only meet the highest industry requirements but also withstand the most demanding audits, providing our clients with lasting reliability and confidence.
Our experts analyze critical process parameters, adapt standard operating procedures (SOPs), and perform risk assessments to secure product quality and compliance. By collaborating closely with equipment vendors and client teams, we minimize downtime, reduce transfer risks, and accelerate qualification timelines. The result is a smooth transition from development to commercial-scale manufacturing while maintaining full GMP and regulatory compliance.
💡 Optivion Engineering delivered a complete GMP-validated solution for pharmaceutical and biotech projects, covering URS development, FAT/SAT supervision, and full IQ/OQ/PQ protocols. By aligning ATEX and GMP compliance with advanced risk management, we ensured reliable system integration, audit-ready documentation, and accelerated production start-up.
📌URS Development & Technical Negotiations
- Drafted detailed User Requirement Specifications (URS) covering ATEX compliance, GMP cleanroom classification, and production capacity.
Conducted technical and economic evaluations of vendor proposals, ensuring alignment with both process requirements and business objectives.
📌Design Qualification & Risk Management
- Prepared Design Qualification (DQ) documentation, integrated HAZOP and risk assessments, and validated ATEX zoning for equipment in explosive-risk environments.
📌Factory & Site Acceptance Testing (FAT/SAT)
- Oversaw FAT procedures to verify supplier compliance before shipment.
Led SAT activities during installation, including integration with MES/SCADA systems and compliance with GMP standards.
📌Equipment Qualification (IQ/OQ/PQ). Executed the full qualification lifecycle:
IQ – Confirmed proper installation and calibration.
OQ – Verified equipment performance under defined operating parameters.
PQ – Validated process reliability under real manufacturing conditions.
📌Compliance Assurance
- Delivered solutions aligned with Annex 1, ATEX 2014/34/EU, 21 CFR Part 11, and ISO 14644.
Ensured audit-ready documentation and inspection support for regulatory bodies.
📌Technology Transfer Solutions
- Optivion Engineering provides expertise in transferring pharmaceutical and biotech processes between different production lines and facilities. Our team ensures that critical process parameters are preserved while adapting the technology to new equipment, layouts, or regulatory environments. By combining technical know-how with GMP compliance, we reduce transfer risks, accelerate time-to-market, and guarantee consistent product quality.
Result
✅ Successful Lecigon Project – Complete technology transfer and scale-up of Lecigon gel manufacturing line, ensuring full GMP compliance and continuous product availability for patients.
✅ ATEX-Certified Equipment Integration – Design, procurement, and validation of production units in explosive-risk environments (ATEX zones), guaranteeing both safety and regulatory compliance.
✅ Automated Filling Line for Creams, Gels, and Ointments – Implementation of a modern tube-filling line with increased productivity and reduced operator intervention, ensuring higher batch-to-batch consistency.
Through our Pharma & Biotech projects, we successfully delivered GMP-compliant solutions, ensuring operational excellence and regulatory readiness. Key achievements include the complete technology transfer – adapting production from one manufacturing line to another with different equipment – the integration of ATEX-certified systems in explosive-risk zones, and the commissioning of a high-capacity tube-filling line. Each project was supported by full URS documentation, FAT/SAT oversight, and IQ/OQ/PQ validation, providing audit-ready deliverables and long-term reliability.
During his career, CEO Marko Pavlović played a key role in the technology transfer and industrialization of Lecigon®, an innovative intestinal gel for Parkinson’s disease. He successfully coordinated process adaptation from development to full-scale production, oversaw validation activities (URS, FAT/SAT, IQ/OQ), and ensured strict GMP compliance. Thanks to his leadership, the first commercial batches were released on time, directly supporting patient access to advanced therapy
1️⃣GMP-Compliant
Cleanroom Installations – designed for safety, sterility, and audit readiness
2️⃣Lecigon Gel Project – from URS drafting to full IQ/OQ/PQ validation
CEO Marko Pavlović led the technology transfer and industrial scale-up of Lecigon®, ensuring GMP compliance and successful commercial production
3️⃣Factory & Site Acceptance Testing (FAT/SAT) – ensuring equipment meets GMP and ATEX requirements before production
4️⃣Comprehensive Validation Packages – URS, FAT/SAT, IQ/OQ/PQ with full traceability for regulatory inspections
5️⃣ATEX-Certified Equipment – safe operations in explosive-risk environments
6️⃣End-to-End Project Management – bridging technical expertise and business value for pharma & biotech clients
Optivion Engineering
Quiet solutions. Powerful results.
Engineering consulting in pharma, biotech, clean-tech, and energy industries. From process simulation to GMP validation and technical cleanliness – reliable, efficient, and audit-ready solutions.