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Project Plan
Project Plan
Guiding Client from Concept to Regulatory Approval
Guiding Client from Concept to Regulatory Approval
4 STEP PROCESS
4 STEP PROCESS
1. Strategic Planning & Regulatory Alignment
1. Strategic Planning & Regulatory Alignment
Objective: Establish a solid foundation by aligning project goals with regulatory requirements.
Feasibility Assessment: Conduct market analysis and feasibility studies to determine project viability.
Regulatory Mapping: Identify applicable regulations (e.g., CDSCO, US FDA, EMA) and ensure compliance from the outset.
Licensing Strategy: Develop a roadmap for obtaining necessary licenses and approvals.
2. Design & Engineering
2. Design & Engineering
Objective: Create a facility that meets operational and regulatory standards.
Conceptual Design: Develop initial layouts and facility designs.
Detailed Engineering: Finalize designs, including HVAC, utilities, and cleanroom specifications.
Compliance Assurance: Ensure designs adhere to GMP, EHS, and other regulatory standards.
3. Construction & Installation
3. Construction & Installation
Objective: Build and equip the facility in line with approved designs.
Construction Management: Oversee civil, mechanical, and electrical works.
Equipment Procurement: Source and install machinery and systems.
System Integration: Ensure seamless integration of all systems for optimal performance.
4. Validation, Qualification & Regulatory Approval
4. Validation, Qualification & Regulatory Approval
Objective: Verify that systems and processes meet regulatory and operational standards.
Commissioning & Qualification: Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems.
Process Validation: Demonstrate that manufacturing processes consistently produce quality products.
Regulatory Submission: Prepare and submit necessary documentation to regulatory authorities for approval.
Approval Acquisition: Secure manufacturing and product licenses.
"From conceptual design to regulatory approval, we provide end-to-end solutions encompassing engineering, compliance, quality assurance, technology transfer, and capacity building, ensuring your pharmaceutical project thrives at every stage."
"From conceptual design to regulatory approval, we provide end-to-end solutions encompassing engineering, compliance, quality assurance, technology transfer, and capacity building, ensuring your pharmaceutical project thrives at every stage."
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