From blueprint
to certificate.
End-to-end pharmaceutical & biotechnology GMP facility setup — for manufacturing sites, R&D and QC laboratories.
Project Management
End-to-end plant setup and GMP certification: a complete project timeline up to certification, and management of every step needed to build a quality system from scratch for manufacturing sites, R&D and QC laboratories.
Commissioning & Qualification
Support for the commissioning and qualification of equipment and utilities in biotechnology manufacturing facilities, R&D and QC laboratories.
Facility Design & Layouts
Review, verification and approval of facility designs and classified cleanrooms, including personnel, material and waste flows that prevent cross-contamination and meet sterile manufacturing principles.
QMS Establishment
Compliant Quality Management Systems designed, built and implemented from the ground up, so your facility meets national and international regulatory standards (TİTCK, FDA, EMA, WHO and PIC/S).
A QMS inspectors recognise.
Built to TİTCK, FDA, EMA, WHO and PIC/S expectations — and to how your facility actually works.
Gap Analysis & Regulatory Strategy
Cleanroom layouts, process flows, procedures and workflows assessed against current guidelines to identify every critical gap — and a clear roadmap to licensing.
Documentation Support
Site Master File, Contamination Control Strategy, SOPs (Deviation, CAPA, Change Control, OOS, Document Management, Training, Audits), BMRs, method validation and technology transfer protocols and reports.
Risk & Validation Management
Quality risk management in line with ICH Q9 and related guidelines, supporting full validation and qualification of critical processes, equipment and systems.
Pre-Approval Mock Audits
Realistic mock audits before official inspections, evaluating your entire quality system and operations so you walk into the inspection prepared.
Turn your vision into an audit-ready facility.
Aligned with EU GMP and global regulatory standards, from day one.