Services
Hands-on engineering and CMC support across the full product lifecycle — from facility design to commercial manufacturing.
Design of GMP manufacturing facilities, layouts, and equipment selection for DS and DP.
Management and oversight of GMP facility construction projects from design to commissioning.
End-to-end transfer execution, from project initiation to PPQ and closure.
End-to-end project management for GMP manufacturing projects, from scope definition to on-site execution and closure.
Evaluation, onboarding, and technical oversight of CDMO partners.
CMC and operational support to deliver clinical and commercial supply.
Equipment qualification from DQ through PQ and process performance execution to support manufacturing readiness.
Design and execution of cleaning validation programs in compliance with GMP requirements.
Validation of computerized systems in GMP environments, ensuring compliance with data integrity requirements.
Preparation for regulatory inspections and GMP compliance.
CMC documentation for regulatory submissions.
Technical training in bioprocess engineering, GMP, and validation.