- Layout design of facilities and cleanrooms in compliance with GMP requirements
- Design of biopharmaceutical production suites (Upstream/Downstream sections)
- HVAC system design for classified cleanrooms
- Utility systems design (WFI, PW, steam, compressed air)
- Bioreactor system design (single-use and stainless steel models)
- Design and layout of chromatography and purification skids
- Design and configuration of filling lines and isolators
- 3D modeling, simulation, and planning of material and personnel flow
- Comprehensive Design and Implementation of Equipment and Process Validation Programs
(Including preparation and execution of IQ, OQ, PQ documents, and Computerized System Validation (CSV) in accordance with international standards)
- Expert Consulting for GMP Compliance and Global Regulatory Approvals
(Providing solutions aligned with FDA, EMA, and WHO standards, along with technical support to achieve necessary certifications)
- Training, Preparation, and Support for Audit and Inspection Processes
(Organizing specialized courses, full facility preparation for audits, conducting mock inspections, and performing gap analyses)
- Preparation and Compilation of Technical and Regulatory Pharmaceutical Documentation (CMC & Regulatory Dossier)
(Professional drafting and editing of CMC documents and regulatory files to facilitate product registration and export)
- Implementation and Enhancement of Integrated Quality Management Systems (QMS)
(Designing, implementing, and updating quality management processes and structures in line with GMP requirements and organizational needs)
- Conducting Specialized Training Courses on GMP, Annex 1, and Validation
- Provision of Preventive Maintenance and Specialized Calibration Services
- Technical Support and Supply of Original Spare Parts
- Specialized Training for Operators, QC and QA Personnel
- Requalification and Gap Analysis of Performance Intervals
- Offering On-site and Remote Technical Support Contracts Customized to Client Needs