Project Management
Our approach to End-to-End Pharmaceutical Commercialization ensures that your product transitions smoothly from clinical phases to full-scale market readiness. We strategically align project milestones with regulatory requirements and business objectives, building a clear, comprehensive roadmap for your entire commercialization lifecycle.
Through detailed management of Technical Operations and Manufacturing Scale-up, our team ensures that your processes are robustly transferred and scaled to meet commercial production goals. We collaborate closely with your technical staff and external partners to mitigate risks, optimize throughput, and ensure that scaled operations maintain the highest standards of product quality and safety.
We provide end-to-end oversight spanning Strategic Partnership and Supply Chain Management. Acting as a true extension of your team, we manage complex partnerships between Brand Owners and CDMOs, coordinating directly with equipment vendors, material suppliers, and logistics companies to ensure the reliable delivery of both clinical and large-scale commercial batches.
- CMO Management
- Drug Commercialization
- PAI Readiness
- Technical Transfer and Batch Scale-up
- Vendor and Procurement Management
- Installation Management
- Hand-over and Start-Up
- Project Plan Development
- Time /Scope /Budget Management
What We Do
- Feasibility Study
- Project Charter
- Proposal
- Kickoff Meeting
- Project Execution Plan
PLAN
- Gantt Chart
- User Requirements Specification (URS)
- Budget
- Project Validation Plan
- Trace Matrix
- Assessments
- Stakeholder Engagement
- Equipment List
- Conceptual Layout
- Flow Diagram
- Resource Schedule
Execute
- Factory Acceptance Testing (FAT)
- Pre-Delivery Inspection (PDI)
- Vendor Coordination
- Change Control
- Site Acceptance Testing (SAT)
- Equipment and Facility Qualification (IQ/OQ/PQ)
- Pre-Start Health and Safety Review (PSHSR)
- Standard Operating Procedures (SOP)
- Document Post-Approval
- Project Punchlist
- Remediation
- Change Control Close
- Handover Documents/Packages
- PQ Readiness
Project Management
Our approach to End-to-End Pharmaceutical Commercialization ensures that your product transitions smoothly from clinical phases to full-scale market readiness. We strategically align project milestones with regulatory requirements and business objectives, building a clear, comprehensive roadmap for your entire commercialization lifecycle.
Through detailed management of Technical Operations and Manufacturing Scale-up, our team ensures that your processes are robustly transferred and scaled to meet commercial production goals. We collaborate closely with your technical staff and external partners to mitigate risks, optimize throughput, and ensure that scaled operations maintain the highest standards of product quality and safety.
We provide end-to-end oversight spanning Strategic Partnership and Supply Chain Management. Acting as a true extension of your team, we manage complex partnerships between Brand Owners and CDMOs, coordinating directly with equipment vendors, material suppliers, and logistics companies to ensure the reliable delivery of both clinical and large-scale commercial batches.
- Time / Scope / Budget
- Due Diligence Reviews
- Vendor Management
- Procurement Management
- Management of Equipment Installation
- Reporting (Work Breakdown Structures)
