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Services
Services
We offer a full suite of services to support medical device manufacturers, pharmaceutical services companies, and CDMO's across the entire product lifecycle. We adapt our approach to your specific technologies, timelines, and regulatory environment ensuring alignment at every step.
Product Development
Product Development
From innovative concept to market-ready solutions, we guide your product developments through every phase with precision and regulatory insight.
Medical Device and Pharmaceutical Container Component product and packaging design brainstorming and design down-selection
Design Controls and Quality by Design (QbD) product development execution
Risk Management
Design for Manufacturability
Project Management
Project Management
Ensuring on-time, on-budget delivery through proven methodologies and meticulous attention to critical path milestones.
Project Planning
Project Scheduling
Project Budget Reporting and Management
Quality Management Systems
Quality Management Systems
Rigorous compliance assessments and risk mitigation strategies that protect your organization and ensure regulatory alignment. Systematic identification and resolution of regulatory gaps to meet evolving standards and maintain market access.
FDA and global compliance readiness
Annex 1 compliance readiness
Inspection preparation & mock audits
Documentation support (SOP’s, batch records)
CAPA and deviation management
Pharma Processing and Package Design
Pharma Processing and Package Design
Innovative solutions for pharmaceutical packaging challenges, optimizing efficiency while ensuring product integrity and compliance.
Fill / Finish and Packaging design consultation
Machining study facilitation and execution.
Track and trace solutions
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