Services

GMP QMS Installation & Optimization​

We design, implement, and optimize QMS frameworks that strengthen quality culture and streamline compliance. From diagnostics to eQMS implementation, we build inspection-ready systems that align with GxP principles while enabling speed, scalability, and operational integrity throughout the product lifecycle.​​

Case Studies

Global QMS Alignment​

 

Development of a unified global GMP QMS for a life sciences organization preparing for both US and EU product filings.​

Insights

Challenge: A global biopharma client was launching acomplex ADC composed of antibody, linker and small-molecule components. Capital constraints and staggered approvals left launch capacity insufficient across raw materials, inputs, conjugation and fill/finish.​

Approach: We mobilized the first TPT: Technical Product Leader, Demand Forecasters, Supply Lead, CMC/Regulatory, Quality, Manufacturing, and Tech-Transfer leads. We back-calculated demand by phase, identified nine additional nodes required across the value chain, assessed sourcing options (greenfield, internal repurpose, arms-length CMO slots, strategic co-investment) and established tech-transfer execution metrics and reporting cadence.​

Impact: Client executed site additions and partner slot buys per the TPT roadmap and achieved on-time, in-full global launch without product supply being a gating constraint. The TPT operating model was adopted portfolio-wide.​

Digital QMS Implementation​

 

Evaluation and implementation of a digital QMS system to take a rapidly growing biopharma from a paper-based to a digital system.​​

Insights

Challenge: A rapidly growing biopharma was utilizing a paper-based QMS system. As assets approached commercial launch, this was becoming cumbersome and impractical for the quality organization to effectively manage.​

Approach: Scimitar led the evaluation, selection, and implementation of a digital QMS solution with the Quality organization and key functional stakeholders. Key business requirements were identified for solution selection, along with a phased rollout plan of which capabilities were required to be deployed at points in time to the organization.​

Impact: The organization was able to successfully migrate from a paper based to a digital QMS system and start managing all operations in the digital system – procedural documentation and quality event management.​

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QMS Controls & Training Optimization for Commercial API Site​

 

Modernization of QMS controls and training to close systemic inspection findings and restore inspection readiness at a commercial API manufacturing site.​

Insights

Challenge: A commercial API site had recurring inspection findings tied to inconsistent change control, incomplete training records, and non-standardized release documentation. The site faced an upcoming regulatory inspection and needed to demonstrate corrective action and sustainable controls.​

Approach: We prioritized high-risk QMS gaps and implemented standardized change-control and training workflows with simplified templates and documented evidence requirements. The program included onsite coaching for QA staff on inspection evidence collection, rollout of a lightweight governance cadence for change approvals, and a targeted documentation clean-up to create an inspection-ready archive. Where feasible, we introduced simple digital trackers (even spreadsheet-based) to improve traceability pending full QMS tool rollout.​

Impact: he site closed multiple recurring observation categories, shortened change-control cycle times, and delivered a coherent archive of inspection evidence. QA leadership regained confidence in release decisions, and the site entered the inspection window with materially improved readiness and demonstrable control over previous findings.​